The effect of sufentanil administration on remifentanil-based anaesthesia during laparoscopic gynaecological surgery: a double-blind randomized controlled trial.
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SUBMITTER: Son I
PROVIDER: S-EPMC4053216 | biostudies-other | 2014
REPOSITORIES: biostudies-other
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Project description:ObjectivesTo examine the efficacy of intratracheal dexmedetomidine (Dex) injection for the prevention of the laryngeal response on emergence from general anaesthesia following gynaecological laparoscopic surgery.DesignProspective, randomised, double-blinded, controlled trial.SettingA general hospital, Guangdong Province, China.ParticipantsAll patients who underwent elective laparoscopic gynaecological surgery, aged 18-60 years old, 40-80?kg in weight, American Society of Anesthesiologists class I-II were eligible. Patients were excluded if they had respiratory disease, heart disorders which might represent risk factors of potential complications of Dex such as bradycardia, heart block, coronary heart disease, uncontrolled hypertension or the long-term use of sedative drugs.InterventionPatients were randomly allocated to either receive intratracheal Dex (DT), intravenous Dex (DV) or intravenous saline (CON, n=30, respectively). In the DT and DV groups, Dex (0.5?µg/kg) was diluted and mixed in 1?or 20?mL of saline, respectively, and injected via the intratracheal or intravenous route 30?min before the completion of the surgery.Outcome measuresThe primary outcome was the coughing extent among the three groups. Secondary outcomes included awareness time, extubation time, postoperative visual analogue scale and Steward recovery score.ResultsCompared with the CON group, the extent of coughing was significantly reduced in both the DV group and the DT group. Furthermore, the mean time to awareness (13.4 (4.3) vs 8.8 (2.9), p<0.001) and the extubation time (14.3 (4.3) vs 8.4 (3.6), p<0.001) were reduced in the DT group. Patients in the DT group also experienced better early recovery quality and less pain than those in the CON group. Furthermore, intratracheal Dex administration contributed to improved stability in haemodynamics with no significant side effects.ConclusionsIntratracheal Dex administration may avoid untoward laryngeal responses for patients emerging from general anaesthesia after gynaecological laparoscopy.Trial registration numberChiCTR-IOR-15007611.
| S-EPMC5898314 | biostudies-literature
Project description:BackgroundIntravenous use of sufentanil can elicit cough. This study aimed to evaluate the inhibitory effect of pre-injection of a mall dose of remifentanil on sufentanil-induced cough during the induction of general anesthesia.MethodsThis prospective, randomized, controlled trial was conducted from January 10, 2019 to March 01, 2019. A total of 100 patients undergoing elective surgery under general anesthesia were enrolled, and at last 84 patients were included and randomly allocated into two equal size groups (n =?42): Patients in the Remifentanil group (R group) received an intravenous infusion of remifentanil 0.3??g/kg (diluted to 2?ml) 1?min before sufentanil injection; patients in the Control group (C group) received 2?ml of normal saline (NS) at the same time point. Injections of patients in both groups were completed within 5?s. Then, sufentanil 0.5??g/kg was injected within 5?s and the number of coughs that occurred within 1?min after sufentanil injection were recorded. One minute after sufentanil injection, etomidate 0.3?mg/kg and cisatracurium 0.15?mg/kg were given for general anesthesia induction irrespective of the presence or absence of cough. The mean arterial pressure (MAP) and heart rate (HR) at time points just before remifentanil pretreatment administration (T0), 3?min after administration (T1), 1?min after intubation (T2), and 3?min after intubation (T3) were recorded.ResultsThe incidence of cough in patients in the R group and C group was 4.8 and 31%, respectively. Compared with group C, the incidence and severity of cough in group R was significantly lower (P <?0.01). No significant differences were observed in MAP and HR at the time of general anesthesia induction between the two groups (P >?0.05).ConclusionPretreatment with a small dose of remifentanil effectively and safely reduced the incidence and severity of cough induced by sufentanil during anesthesia induction and can be used as an alternative treatment to inhibit coughing caused by sufentanil.Trial registrationChinese Clinical Trial Registry (ChiCTR1900020587, registered date: January 9, 2019), http://www.chictr.org.cn.
| S-EPMC6712682 | biostudies-literature
Project description:The study was designed to investigate postoperative nausea and vomiting (PONV) in low- and high-dose remifentanil regimens for total intravenous anaesthesia (TIVA) in adult female patients with American Society of Anaesthesiologists physical status classification I undergoing local breast excision. Propofol and remifentanil 5 ng · mL(-1) (L group) or 10 ng · mL(-1) (H group) were administered for anaesthesia induction and maintenance. Propofol was titrated within range of 0.1 μg · mL(-1) to maintain bispectral index (BIS) values between 40 and 60. Haemodynamic parameters during the intra- and postoperative periods and 24 h postoperative visual analogue scale (VAS) and PONV were evaluated. Each group with 63 patients was analyzed. The H group showed higher use of remifentanil and lower use of propofol, with similar recovery time. Mean systemic arterial blood pressure (MBP), heart rate, and BIS did not differ significantly before and after endotracheal intubation in the H group. However, significant increases in MBP and BIS were apparent in the L group. Postoperative VAS, PONV incidence and scale, and Rhodes index did not differ significantly between the two groups. In conclusion, TIVA with high-dose remifentanil did not aggravate PONV with similar postoperative pain, compared with low-dose remifentanil. Furthermore, high-dose remifentanil showed more haemodynamic stability after endotracheal intubation. This trial is registered with KCT0000185.
| S-EPMC4065760 | biostudies-other
Project description:OBJECTIVE:To evaluate whether retrofilling the bladder upon completion of elective laparoscopic gynecologic surgery for benign indications has an effect on the timing of the first post-operative void and timing of discharge from hospital. DESIGN:Double-blind randomized controlled trial SETTING: Single academic surgical day hospital PATIENTS: Patients undergoing outpatient laparoscopic gynecologic surgery, excluding hysterectomy or pelvic reconstructive surgery. INTERVENTIONS:Upon completion of surgery, patients were randomized to either retrograde filling of the bladder with 200 mL of saline prior to catheter removal or standard care (immediate catheter removal). Patients and PACU nurses (outcome assessors) were both blinded. MEASUREMENTS:The primary outcome was the time to first void. Secondary outcomes were time to hospital discharge, post-operative urinary tract infection and patient satisfaction. MAIN RESULTS:Over a 3 month period, 47 patients were approached on the day of surgery, 42 consented and were randomized (21 to intervention and 21 to control). There were no significant differences in baseline demographics between groups. The median time to first void was significantly shorter for patients in the intervention arm compared to controls (104 ± 75min vs 162 ± 76min, p<0.001). Retrofilled patients were discharged faster from PACU compared to controls (155.0 ± 74min vs 227 ± 58min, p=0.001). There were no urinary tract infections in either group and the proportion of satisfied or very satisfied patients was high (93.8% vs. 88.2%, p=0.512). CONCLUSION:Retrograde filling the bladder after outpatient laparoscopic gynecologic surgery is a safe, effective method that significantly reduces length of hospital stay.
| S-EPMC7532349 | biostudies-literature
Project description:Background and Aims:Using remifentanil-propofol target-controlled infusion (TCI) in open gynaecological surgeries could be associated with opioid-induced hyperalgesia postoperatively. This study's aim was to investigate the effect of low-dose S-ketamine compared with control on cumulative morphine consumption 24 h postoperatively in women undergoing open abdominal hysterectomy with remifentanil-propofol TCI technique. Methods:Ninety female patients above 21 years old who underwent elective open abdominal hysterectomy under general anaesthesia with remifentanil-propofol TCI were recruited. They were randomised to receive either normal saline as control (n = 44) or 0.25 mg/kg intravenous boluses of S-ketamine before skin incision and after complete removal of uterus (n = 45). The primary outcome measure was cumulative morphine consumption measured over 24 h postoperatively. The secondary outcome measures were incidences of opioid-related and psychotomimetic side effects, pain and level of sedation scores. Results:The cumulative 24-h morphine consumption postoperatively (P = 0.0547) did not differ between both the groups. S-ketamine group had slower emergence from general anaesthesia (P = 0.0308) and lower pain scores (P = 0.0359) 15 min postoperatively. Sedation level, common opioid-related side effects (nausea, vomiting, pruritus), respiratory depression and psychotomimetic side effects were similar between both the study groups. Conclusion:Low-dose S-ketamine did not reduce the total cumulative morphine consumption in patients undergoing major open gynaecological surgeries with remifentanil-propofol TCI.
| S-EPMC6383487 | biostudies-literature
Project description:Background: The incidence of postoperative nausea and vomiting (PONV) remains high. The effects of sufentanil for PONV is not firmly confirmed. The aim of this study was to compare the effect of sufentanil- and fentanyl-based intravenous patient-controlled analgesia (IV-PCA) on the incidence of PONV after laparoscopic nephrectomy. Methods: Eighty-six patients were randomly allocated to receive either the sufentanil (n =43) or fentanyl (n =43). IV-PCA was prepared using either sufentanil 3 µg/kg or fentanyl 20 µg/kg, ramosetron 0.3 mg, and ketorolac 120 mg. The primary outcome of was the incidence of PONV during 24 h after post anesthesia care unit (PACU) discharge. The secondary outcomes were the modified Rhodes index and patient satisfaction scores at 24 h after PACU discharge, need for rescue antiemetics, pain score, need for additional analgesics, and cumulative consumption of IV-PCA Results: The incidence of PONV was comparable between the sufentanil and fentanyl groups (64.3% vs. 65%, p = 0.946; respectively). The number of patients who required antiemetics (p = 0.946) and the modified Rhodes index at 24 h after post-anesthesia care unit discharge (p = 0.668) were also comparable in both groups. No significant differences were found in the secondary outcomes, including the analgesic profiles and adverse events between the groups. Conclusions: In conclusion, sufentanil- and fentanyl-based IV-PCA showed similar incidence of PONV with comparable analgesic effects after laparoscopic nephrectomy. Based on these results, we suggest that sufentanil and fentanyl may provide comparable effects for IV-PCA after laparoscopic nephrectomy.
| S-EPMC6990885 | biostudies-literature
Project description:BACKGROUND:Balanced anaesthesia with propofol and remifentanil, compared to sufentanil, often decreases mean arterial pressure (MAP), heart rate (HR) and cardiac index (CI), raising concerns on tissue-oxygenation. This distinct haemodynamic suppression might be attenuated by atropine. This double blinded RCT, investigates if induction with propofol-sufentanil results in higher CI and tissue-oxygenation than with propofol-remifentanil and if atropine has more pronounced beneficial effects on CI and tissue-oxygenation in a remifentanil-based anaesthesia. METHODS:In seventy patients scheduled for coronary bypass grafting (CABG), anaesthesia was induced and maintained with propofol target controlled infusion (TCI) with a target effect-site concentration (Cet) of 2.0??g?ml-?1 and either sufentanil (TCI Cet 0.48?ng?ml-?1) or remifentanil (TCI Cet 8?ng?ml-?1). If HR dropped below 60?bpm, methylatropine (1?mg) was administered intravenously. Relative changes (?) in MAP, HR, stroke volume (SV), CI and cerebral (SctO2) and peripheral (SptO2) tissue-oxygenation during induction of anaesthesia and after atropine administration were analysed. RESULTS:The sufentanil group compared to the remifentanil group showed significantly less decrease in MAP (??=?-?23?±?13 vs. -36?±?13?mmHg), HR (??=?-?5?±?7 vs. -10?±?10?bpm), SV (??=?-?23?±?18 vs. -35?±?19?ml) and CI (??=?-?0.8 (-?1.5 to -?0.5) vs. -1.5 (-?2.0 to -?1.1) l min-?1?m-?2), while SctO2 (??=?9?±?5 vs. 6?±?4%) showed more increase with no difference in ?SptO2 (??=?8?±?7 vs. 8?±?8%). Atropine caused higher ?HR (13 (9 to 19) vs. 10?±?6?bpm) and ?CI (0.4?±?0.4 vs. 0.2?±?0.3?l?min-?1?m-?2) in sufentanil vs. remifentanil-based anaesthesia, with no difference in ?MAP, ?SV and ?SctO2 and ?SptO2. CONCLUSION:Induction of anaesthesia with propofol and sufentanil results in improved haemodynamic stability and higher SctO2 compared to propofol and remifentanil in patients having CABG. Administration of atropine might be useful to counteract or prevent the haemodynamic suppression associated with these opioids. TRIAL REGISTRATION:Clinicaltrials.gov on June 7, 2013 (trial ID: NCT01871935 ).
| S-EPMC7541228 | biostudies-literature
Project description:BackgroundThe present study was to compare the potential impact of remifentanil-based propofol-supplemented anesthesia regimen vs. conventional sevoflurane-sufentanil balanced anesthesia on postoperative recovery of consciousness indicated by bispectral index (BIS) values in patients undergoing cardiac surgery.MethodsPatients undergoing cardiac surgery were randomly allocated to get the remifentanil-based propofol-supplemented anesthesia employing target-controlled infusion (TCI) of remifentanil and propofol (Group-PR, n = 15) or a balanced-anesthesia employing sevoflurane-inhalation and TCI-sufentanil (Group-C, n = 19). In Group-PR, plasma concentration (Cp) of TCI-remifentanil was fixed at 20 ng/ml, and the effect-site concentration of TCI-propofol was adjusted within 0.8-2.0 ?g/ml to maintain BIS value of 40-60. In Group-C, sevoflurane dosage was adjusted within 1-1.5 minimum alveolar concentration to maintain BIS of 40-60, and Cp of TCI-sufentanil was fixed at 0.4 ng/ml. The inter-group difference in the time for achieving postoperative BIS > 80 (T-BIS80) in the intensive care unit was determined as the primary outcome. The inter-group difference in the extubation time was determined as the secondary outcome.ResultsT-BIS80, was shorter in Group-PR than Group-C (121.4 ± 64.9 min vs. 182.9 ± 85.1 min, respectively; the difference of means -61.5 min; 95% CI -115.7 to -7.4 min; effect size 0.812; P = 0.027). The extubation time was shorter in Group-PR than in Group-C (434.7 ± 131.3 min vs. 946.6 ± 393.3 min, respectively, P < 0.001).ConclusionsCompared with the conventional sevoflurane-sufentanil balanced anesthesia, the remifentanil-based propofol-supplemented anesthesia showed significantly faster postoperative conscious recovery in patients undergoing cardiac surgery.
| S-EPMC7724124 | biostudies-literature
Project description:BackgroundIntravenous morphine (IVM) is the most common strong analgesic used in trauma, but is associated with a clear time limitation related to the need to obtain an access route. The intranasal (IN) route provides easy administration with a fast peak action time due to high vascularization and the absence of first-pass metabolism. We aimed to determine whether IN sufentanil (INS) for patients presenting to an emergency department with acute severe traumatic pain results in a reduction in pain intensity non-inferior to IVM.Methods and findingsIn a prospective, randomized, multicenter non-inferiority trial conducted in the emergency departments of 6 hospitals across France, patients were randomized 1:1 to INS titration (0.3 μg/kg and additional doses of 0.15 μg/kg at 10 minutes and 20 minutes if numerical pain rating scale [NRS] > 3) and intravenous placebo, or to IVM (0.1 mg/kg and additional doses of 0.05 mg/kg at 10 minutes and 20 minutes if NRS > 3) and IN placebo. Patients, clinical staff, and research staff were blinded to the treatment allocation. The primary endpoint was the total decrease on NRS at 30 minutes after first administration. The prespecified non-inferiority margin was -1.3 on the NRS. The primary outcome was analyzed per protocol. Adverse events were prospectively recorded during 4 hours. Among the 194 patients enrolled in the emergency department cohort between November 4, 2013, and April 10, 2016, 157 were randomized, and the protocol was correctly administered in 136 (69 IVM group, 67 INS group, per protocol population, 76% men, median age 40 [IQR 29 to 54] years). The mean difference between NRS at first administration and NRS at 30 minutes was -4.1 (97.5% CI -4.6 to -3.6) in the IVM group and -5.2 (97.5% CI -5.7 to -4.6) in the INS group. Non-inferiority was demonstrated (p < 0.001 with 1-sided mean-equivalence t test), as the lower 97.5% confidence interval of 0.29 (97.5% CI 0.29 to 1.93) was above the prespecified margin of -1.3. INS was superior to IVM (intention to treat analysis: p = 0.034), but without a clinically significant difference in mean NRS between groups. Six severe adverse events were observed in the INS group and 2 in the IVM group (number needed to harm: 17), including an apparent imbalance for hypoxemia (3 in the INS group versus 1 in the IVM group) and for bradypnea (2 in the INS group versus 0 in the IVM group). The main limitation of the study was that the choice of concomitant analgesics, when they were used, was left to the discretion of the physician in charge, and co-analgesia was more often used in the IVM group. Moreover, the size of the study did not allow us to conclude with certainty about the safety of INS in emergency settings.ConclusionsWe confirm the non-inferiority of INS compared to IVM for pain reduction at 30 minutes after administration in patients with severe traumatic pain presenting to an emergency department. The IN route, with no need to obtain a venous route, may allow early and effective analgesia in emergency settings and in difficult situations. Confirmation of the safety profile of INS will require further larger studies.Trial registrationClinicalTrials.gov NCT02095366. EudraCT 2013-001665-16.
| S-EPMC6634380 | biostudies-literature
Project description:Background: Remifentanil-induced hyperalgesia (r-IH) involves an imbalance in the inhibitory and excitatory systems. As the transcranial Direct Current Stimulation (tDCS) modulates the thalamocortical synapses in a top-down manner, we hypothesized that the active (a)-t-DCS would be more effective than sham(s)-tDCS to prevent r-IH. We used an experimental paradigm to induce temporal summation of pain utilizing a repetitive cold test (rCOLDT) assessed by the Numerical Pain Score (NPS 0-10) and we evaluated the function of the descending pain modulatory system (DPMS) by the change on the NPS (0-10) during the conditioned pain modulation (CPM)-task (primary outcomes). We tested whether a-tDCS would be more effective than s-tDCS to improve pain perception assessed by the heat pain threshold (HPT) and the reaction time during the ice-water pain test (IPT) (secondary outcomes). Methods: This double-blinded, factorial randomized trial included 48 healthy males, ages ranging 19-40 years. They were randomized into four equal groups: a-tDCS/saline, s-tDCS/saline, a-tDCS/remifentanil and s-tDCS/remifentanil. tDCS was applied over the primary motor cortex, during 20 min at 2 mA, which was introduced 10 min after starting remifentanil infusion at 0.06 ?g?kg-1?min-1 or saline. Results: An ANCOVA mixed model revealed that during the rCOLDT, there was a significant main effect on the NPS scores (F = 3.81; P = 0.01). The s-tDCS/remifentanil group presented larger pain scores during rCOLDT, [mean (SD) 5.49 (1.04)] and a-tDCS/remifentanil group had relative lower pain scores [4.15 (1.62)]; showing its blocking effect on r-IH. a-tDCS/saline and s-tDCS/saline groups showed lowest pain scores during rCOLDT, [3.11 (1.2)] and [3.15 (1.62)], respectively. The effect of sedation induced by remifentanil during the rCOLDT was not significant (F = 0.76; P = 0.38). Remifentanil groups showed positive scores in the NPS (0-10) during the CPM-task, that is, it produced a disengagement of the DPMS. Also, s-tDCS/Remifentanil compared to a-tDCS showed lower HPT and larger reaction-time during the IPT. Conclusion: These findings suggest that effects of a-tDCS prevent the summation response induced by r-IH during rCOLDT and the a-tDCS blocked the disengagement of DPMS. Thereby, tDCS could be considered as a new approach to contra-regulate paradoxical mechanisms involved in the r-IH. Clinical trials identification: NCT02432677. URL:https://clinicaltrials.gov/.
| S-EPMC5825908 | biostudies-literature