Dataset Information

Effect of desmopressin on bleeding during endoscopic sinus surgery: A randomized clinical trial.

ABSTRACT:

Background

This study aimed to evaluate the effect of local nasal desmopressin premedication on blood loss and the quality of surgical field in Functional Endoscopic Sinus Surgery (FESS).

Material and methods

In a randomized clinical trial, patients referred for FESS to treat their bilateral chronic rhinosinusitis were recruited. The participants were adults (≥18 years). They were randomly assigned (1:1:1) to receive low-dose (20 μg) or high-dose (40 μg) intranasal desmopressin (DDAVP) or placebo 60 min before the induction of general anesthesia. Standard FESS was performed by the same surgeon. The primary outcomes were volume of intraoperative bleeding and the quality of surgical field. Clean surgical field was defined as a score ≤2 on the Boezaart grading system.

Results

A total of 120 patients were included on an intention-to-treat basis (mean age: 41.0 years; 40 women, 80 men). There were no significant differences in primary outcomes between low-dose DDAVP and placebo. As for the volume of blood loss, however, there was a significant difference between high-dose DDAVP and placebo (mean difference: 29.6 ml; adjusted Cohen's d: -1.02; p < .001). Also, in the high-dose DDAVP, the probability of having a good surgical field over time was about two times higher than in the placebo group (RRs for first and second surgical sides: 1.89 and 2.18). The number needed to treat for the two time points was 1.6 and 1.3, respectively.

Conclusion

The present study showed that the use of desmopressin at a dose of 40 μg 1 h before surgery can reduce bleeding and improve the quality of the surgical field. Further studies are recommended to be able to generalize these findings to other ENT surgeries.

Level of evidence

1b.

SUBMITTER: Akbarpour M

PROVIDER: S-EPMC9392372 | biostudies-literature | 2022 Aug

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Effect of desmopressin on bleeding during endoscopic sinus surgery: A randomized clinical trial.

Akbarpour Maliheh M Jalali Mir Mohammad MM Akbari Maryam M Haddadi Soudabeh S Fani Ghaffar G

Laryngoscope investigative otolaryngology 20220624 4

<h4>Background</h4>This study aimed to evaluate the effect of local nasal desmopressin premedication on blood loss and the quality of surgical field in Functional Endoscopic Sinus Surgery (FESS).<h4>Material and methods</h4>In a randomized clinical trial, patients referred for FESS to treat their bilateral chronic rhinosinusitis were recruited. The participants were adults (≥18 years). They were randomly assigned (1:1:1) to receive low-dose (20 μg) or high-dose (40 μg) intranasal desmopressin (D ...[more]

PMID: 36000037

Similar Datasets

Project description:Background:Bleeding during surgery can lead to serious complications. Methods and drugs to control bleeding are always important both for the surgeon and anesthesiologist, especially in endoscopic procedures. A lot of efforts are made to optimize the surgical conditions for functional endoscopic sinus surgery. Induced hypotension is widely advocated to prevent bleeding and consequently to improve the quality of an operation . Amongst the pharmacological agents, dexmedetomidine is the most recently introduced drug to provide hypotensive anesthesia during functional endoscopic sinus surgery. Objectives:The current study aimed at investigating the effects of intravenous infusion of dexmedetomidine on bleeding, nausea, awakening time, and other intravenous anesthetic doses during functional endoscopic sinus surgery. Methods:Sixty patients aged 16 to 60 years with American society of anesthesiologists (ASA) class I or II in Imam Khomeini hospital of Ahvaz, Iran, who were the candidate for the elective functional endoscopic sinus surgery were enrolled in the current double-blind clinical trial. They were randomly divided into 2 groups: group D (receiving dexmedetomidine), and group N (receiving normal saline). Sampling was based on the block randomization method. In group D, a 1-?g/kg dexmedetomidine was injected during 10 minutes just before the induction. Then, 0.5 µg/ kg/ hour infusion was started. Both groups had the same induction and maintenance method as well as the drugs administered for general anesthesia induction. For maintenance, the patients received O2 50%: N2O 50% and 100 ?g/kg/minute of propofol and 0.2 ?g/kg/minute of remifentanil. In group N, instead of dexmedetomidine in bolus and maintenance, normal saline was used with the same volume. Mean arterial pressure was maintained between 65 to 75 mmHg. The incidence of bleeding, nausea and vomiting after surgery, the amount of maintenance drugs, and awakening time were recorded in a checklist. Results:The intravenous use of dexmedetomidine significantly reduced the amount of bleeding (P < 0.0001); in addition, the need for opioids (P < 0.0001) and intravenous anesthetics significantly decreased (P = 0.001). Awakening time was significantly longer (P = 0.001), but its effect on postoperative nausea and vomiting was not significant (P = 0.052). Conclusions:The current study showed that although propofol and remifentanil compounds can control hemodynamic state, but intravenous infusion of dexmedetomidine during the functional endoscopic sinus surgery reduced the amount of bleeding more significantly. It also reduced the dosage of maintenance drugs.

Project description:ImportanceThe opioid epidemic has generated interest in optimizing opioid prescribing after common surgeries. Recent studies have shown a broad range of analgesic prescription patterns following endoscopic sinus surgery (ESS).ObjectiveTo compare the efficacy of different analgesic regimens after ESS.Design, setting, and participantsThis multi-institutional, nonblinded randomized clinical trial was conducted at 6 tertiary centers across the US and Canada and included participants who underwent ESS for acute or chronic rhinosinusitis. The study was conducted from March 2019 to March 2020, and the data were analyzed in November to December 2020.InterventionsAll participants received acetaminophen, 650 mg, as the first-line analgesic. From there, patients were randomized to either oxycodone rescue (oxycodone, 5 mg, as second-line therapy) or ibuprofen rescue (ibuprofen, 600 mg, as second-line therapy, with oxycodone, 5 mg, reserved for breakthrough pain).Main outcomes and measuresBaseline characteristics and disease severity were collected at enrollment. Medication logs, pain scores, and epistaxis measures were collected until postoperative day 7. The primary outcome was the postoperative visual analog scale score for pain. Brief Pain Inventory Pain Severity and Pain Interference Scores were also collected.ResultsA total of 118 patients were randomized (62 [52.5%] oxycodone rescue, 56 [47.5%] ibuprofen rescue; mean [SD] age, 46.7 [16.3] years; 44 women [44.0%]; 83 White [83.0%], 7 Black [7.0%], and 7 Asian individuals [7.0%]). After exclusions for loss to follow-up and noncompliance, 51 remained in the oxycodone rescue group and 49 in the ibuprofen rescue group. The groups had similar demographic characteristics and disease severity. Thirty-two (63%) in the oxycodone rescue group had adequate pain management with acetaminophen only, while 19 (37%) consumed at least 1 oxycodone dose. In the ibuprofen rescue group, 18 (16%) required only acetaminophen, 28 (57%) used only acetaminophen and ibuprofen, and the remaining 13 (26%) consumed 1 or more oxycodone doses. The groups had similar average acetaminophen (9.69 vs 7.96 doses; difference, 1.73; 95% CI, -1.37 to 4.83) and oxycodone (1.89 vs 0.77 doses; difference, 1.13; 95% CI, -0.11 to 2.36) use. Both groups had similar postoperative visual analog scale scores. A subanalysis that compared opioids users with nonusers showed clinically significant lower pain scores in nonusers at multiple postoperative points.Conclusions and relevanceIn this randomized clinical trial, most patients who underwent ESS could be treated postoperatively using a nonopioid regimen of either acetaminophen alone or acetaminophen and ibuprofen. Ibuprofen as a second-line therapy did not reduce overall narcotic consumption, but the overall narcotic use was low in both groups.Trial registrationClinicalTrials.gov Identifier: NCT03783702.

Project description:ObjectivesImproved intraoperative visibility during functional endoscopic sinus surgery (FESS) decreases the risk of serious orbital or skull base injuries. Esmolol and labetalol have been used to reduce bleeding and achieve better visibility, but it remains unclear which drug is more effective. This study aims to measure visibility scores and mucosal bleeding rates for esmolol and labetalol in FESS.MethodsThis is a 1-year randomized double-blind trial of adults undergoing FESS at a tertiary academic center. The inclusion criteria were as follows: age 18 or older; history of chronic rhinosinusitis (CRS) with or without nasal polyps; undergoing FESS for CRS; and American Society of Anesthesiologists (ASA) physical status 1 (healthy) or 2 (patient with mild systemic disease). The exclusion criteria were as follows: pregnancy; asthma, chronic obstructive pulmonary disease (COPD), bradycardia, heart failure, end-stage renal disease, cerebrovascular accident, diabetes mellitus; preoperative use of nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin, or beta-blockers; and body mass index (BMI) greater than 40 kg/m2. Patients received either dose-infused esmolol or intravenous push labetalol. The primary outcome was intraoperative visibility determined by surgeon using validated scoring systems (Boezaart, Wormald). The secondary outcome was hemodynamic control (rate of blood loss, average mean arterial pressure [MAP], average heart rate [HR]). Hypothesis of no difference between drugs formed before data collection.ResultsOf the 32 adults given drug (mean age = 50), 28 patients (13 esmolol and 15 labetalol) with complete data were included in the final analysis. There were no statistically significant differences between esmolol and labetalol in rate of blood loss (0.59 [0.28] vs 0.66 [0.37] mL/min, P = 0.62), average MAP (79.7 [7.5] vs 79.4 [7.7] mm Hg, P = .93), HR (72 [8.7] vs 68 [11.7] bpm, P = .26), or mean visibility scores for the Boezaart (3.1 [0.69] vs 3.1 [0.89], P = .85) and Wormald (6.1 [1.7] vs 5.9 [1.9], P = .72) grading scales.ConclusionsThere were no significant differences between esmolol and labetalol in rate of blood loss, MAP control, HR, or surgical visibility in FESS. Either drug may be used, and other considerations (availability, cost) can dictate choice.

Project description:ImportanceAlthough oral corticosteroids are commonly prescribed following endoscopic sinus surgery (ESS) for chronic rhinosinusitis (CRS) without nasal polyposis, there are little data to suggest that this is a beneficial practice.ObjectiveTo assess the efficacy of oral corticosteroids following ESS in CRS without polyps.Design, setting, and participantsThis prospective double-blinded, placebo-controlled, randomized noninferiority clinical trial conducted in a single academic tertiary rhinology practice included adults with CRS without polyps undergoing ESS. Of 81 patients recruited, 72 completed the study.InterventionsPatients were randomized into 2 treatment groups: a 12-day postoperative taper of oral prednisone vs matched placebo tablets. All study patients also received a uniform 2-week postoperative regimen of oral antibiotics, fluticasone nasal spray, and saline rinses.Main outcomes and measuresThe primary outcome measures were Sinonasal Outcome Test-22 (SNOT-22) scores and Lund-Kennedy endoscopy scores, collected preoperatively and postoperatively at 1 week, 1 month, 3 months, and 6 months. Scores were compared between treatment groups at each time point using longitudinal difference between treatment groups and analyzed using 2-way, repeated measures analysis of variance. Secondary outcome measures included treatment-related adverse effects.ResultsOverall, 72 patients (mean [SD] age, 49.4 [14.9] years; 36 men, 36 women) completed the study, with 33 in the prednisone arm and 39 in the placebo arm. When comparing longitudinal differences between treatment groups, there was no clinically meaningful difference observed in SNOT-22 total (F[4254] = 1.71, η2 = 0.01 [95% CI, 0.00-0.05]) or Lund-Kennedy scores (F[4247] = 1.23, η2 = 0.02 [95% CI, 0.00-0.50]). In SNOT-22 subdomain analyses, there was no clinically meaningful difference between treatment groups for rhinologic, extranasal rhinologic, ear/facial, or sleep subdomains. However, the prednisone group had worse longitudinal scores for psychological dysfunction compared with the placebo group (F[4254] = 3.18, η2 = 0.05 [95% CI, 0.02-0.09]). Reported adverse effects were similar between the 2 treatment groups.Conclusions and relevanceIn this randomized clinical trial of patients with CRS without polyps, oral prednisone following ESS conferred no additional benefit over placebo in terms of SNOT-22 total scores, SNOT-22 rhinologic subscores, or Lund-Kennedy endoscopy scores up to 6 months after surgery. Patients receiving prednisone, however, did demonstrate worse SNOT-22 psychologic subdomain scores. These results suggest that the risks of oral corticosteroids may outweigh the benefits; thus use of oral corticosteroids after ESS for CRS without polyps should be carefully considered.Trial registrationClinicalTrials.gov Identifier: NCT02748070.

Project description:ImportanceIntravenous acetaminophen is a commonly prescribed analgesic for the prevention and treatment of postsurgical pain. Its efficacy in the context of endoscopic sinus surgery (ESS) has yielded mixed results.ObjectiveTo compare the efficacy of perioperative intravenous acetaminophen (IVAPAP) with that of placebo in improving early postoperative pain after endoscopic sinus surgery (ESS).Design, setting, and participantsA prospective, randomized clinical trial including 62 patients undergoing ESS for chronic rhinosinusitis in a single tertiary referral hospital.InterventionsParticipants were randomized to receive 1 g of IVAPAP or 100 mL of placebo consisting of saline infusions immediately before the start of surgery and 4 hours after the initial dose.Main outcomes and measuresThe primary outcome was postoperative pain measured by visual analog scale (VAS) scores up to 24 hours after surgery by blinded observers. Secondary endpoints included postoperative opioid (intravenous and oral) use and adverse events in the 24-hour postoperative period.ResultsOf the 62 enrolled adult participants, 60 were randomized (31 to IVAPAP intervention and 29 to placebo). The mean (SD) age of participants was 53.7 (14.7) years and 35 (58%) of the participants were men and 25 (42%) were women. Within the first hour, mean pain scores were reduced in the IVAPAP group compared with the control group, reaching a maximum difference of 7.7 mm on a VAS scale favoring the treatment group with a true difference possibly as high as 22 mm, and the data are compatible with a clinically meaningful difference. At 12- and 24-hours, average pain scores were less in the placebo group and the data are compatible with a clinically meaningful difference of 5.8 (-5.2 to 16.8) and 8.2 (-1.9 to 18.4), respectively, favoring the placebo group. However, at all time points the CIs included the null value and were wide, thus preventing definitive conclusions. Inspection of the secondary outcomes favored IVAPAP, but the wide range of the CIs and inclusion of the null value prevent definitive conclusions.Conclusions and relevanceThe results of this study are inconclusive. The data suggest that perioperative intravenous acetaminophen may reduce immediate postoperative pain and opioid requirements compared with placebo and these differences could be clinically meaningful. Unfortunately, the imprecision of the estimates prevents definitive conclusion. Use of IVAPAP does not seem to increase adverse events.Trial registrationclinicaltrials.gov Identifier: NCT01608308.

Dataset Information

Effect of desmopressin on bleeding during endoscopic sinus surgery: A randomized clinical trial.

Background

Material and methods

Results

Conclusion

Level of evidence

Publications

Effect of desmopressin on bleeding during endoscopic sinus surgery: A randomized clinical trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets