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A randomized trial of phenylephrine infusion versus bolus dosing for nausea and vomiting during Cesarean delivery in obese women.

ABSTRACT: PURPOSE:Hypotension is common after spinal anesthesia for Cesarean delivery. It is associated with nausea, vomiting, and fetal acidosis. Previous research on phenylephrine excluded obese subjects. We compared the incidence of intraoperative nausea and vomiting (IONV) in obese patients who received a prophylactic phenylephrine infusion vs those who received bolus dosing for the treatment of spinal-induced hypotension. METHODS:In this multicentre, double-blinded randomized controlled trial, 160 obese women undergoing elective Cesarean delivery under spinal anesthesia were randomized to receive a prophylactic phenylephrine infusion initiated at 50 ?g·min-1 (and titrated according to a predefined algorithm) or 100 ?g phenylephrine boluses to treat hypotension. Maternal systolic blood pressure was maintained within 20% of baseline. The primary study outcome was the incidence of IONV. RESULTS:Intraoperative nausea and vomiting were significantly reduced in the infusion group compared to the bolus group (46% vs 75%, respectively; relative risk [RR], 0.61; 95% confidence interval [CI], 0.47 to 0.80; P < 0.001). This was associated with significantly reduced need for intraoperative rescue antiemetics (26% vs 42%, respectively; RR, 0.62; 95% CI, 0.40 to 0.97; P = 0.04), but no difference in the incidence of vomiting. Postoperative vomiting at two hours was reduced in the infusion group (11% vs 25%; RR, 0.44; 95% CI, 0.21 to 0.90; P = 0.02);however, there were no differences in the incidence or severity of postoperative nausea, need for rescue antiemetics at two hours and 24 hr, or the incidence of postoperative vomiting at 24 hr. CONCLUSION:In obese women undergoing Cesarean delivery with spinal anesthesia, prophylactic phenylephrine infusion was associated with less intraoperative nausea, less need for rescue antiemetics, and reduced early postoperative vomiting. TRIAL REGISTRATION:www.clinicaltrials.gov (NCT01481740). Registered 22 July 2011.

SUBMITTER: George RB

PROVIDER: S-EPMC5856192 | biostudies-literature | 2018 Mar

REPOSITORIES: biostudies-literature

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A randomized trial of phenylephrine infusion versus bolus dosing for nausea and vomiting during Cesarean delivery in obese women.

George Ronald B RB McKeen Dolores M DM Dominguez Jennifer E JE Allen Terrence K TK Doyle Patricia A PA Habib Ashraf S AS

Canadian journal of anaesthesia = Journal canadien d'anesthesie 20171205 3

<h4>Purpose</h4>Hypotension is common after spinal anesthesia for Cesarean delivery. It is associated with nausea, vomiting, and fetal acidosis. Previous research on phenylephrine excluded obese subjects. We compared the incidence of intraoperative nausea and vomiting (IONV) in obese patients who received a prophylactic phenylephrine infusion vs those who received bolus dosing for the treatment of spinal-induced hypotension.<h4>Methods</h4>In this multicentre, double-blinded randomized controlle ...[more]

PMID: 29209926

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Project description:BACKGROUND:Phenylephrine is the most commonly used vasopressor for prophylaxis against maternal hypotension during cesarean delivery; however, the best regimen for its administration is not well established. Although variable infusion protocols had been suggested for phenylephrine infusion, evidence-based evaluation of variable infusion regimens are lacking. The aim of this work is to compare variable infusion, fixed on-and-off infusion, and intermittent boluses of phenylephrine for prophylaxis against maternal hypotension during cesarean delivery. METHODS:A randomized controlled study was conducted, including full-term pregnant women scheduled for elective cesarean delivery. Participants were divided into three groups which received phenylephrine by either intermittent boluses (1.5 mcg/Kg phenylephrine), fixed on-and-off infusion (with a dose of 0.75 mcg/Kg/min), or variable infusion (with a starting dose of 0.75 mcg/Kg/min). The three groups were compared with regard to frequency of: maternal hypotension (primary outcome), second episode hypotension, reactive hypertension, and bradycardia. Other outcomes included heart rate, systolic blood pressure, physician interventions, and neonatal outcomes. RESULTS:Two-hundred and seventeen mothers were available for final analysis. The 2 infusion groups showed less incidence of maternal hypotension {26/70 (37%), 22/71 (31%), and (51/76 (67%)} and higher incidence of reactive hypertension compared to the intermittent boluses group without significant differences between the two former groups. The number of physician interventions was highest in the variable infusion group compared to the other two groups. The intermittent boluses group showed lower systolic blood pressure and higher heart rate compared to the two infusion groups; whilst the two later groups were comparable. CONCLUSION:Both phenylephrine infusion regimens equally prevented maternal hypotension during cesarean delivery compared to intermittent boluses regimen. Due to higher number of physician interventions in the variable infusion regimen, the current recommendations which favor this regimen over fixed infusion regimen might need re-evaluation.

Project description:ObjectiveThis study aimed to evaluate the effect of a novel antimicrobial dressing on patient satisfaction and health-related quality of life (HRQoL) following a cesarean delivery.Study designThis was an open-label, single-center, two-arm randomized controlled trial. This study was done at the tertiary center, maternal unit, Galveston, TX. Pregnant women with body mass indices ≥35 kg/m2 were screened for eligibility. Women were randomized to ReliaTect Post-Op Dressing (RELIATECT) or standard wound dressing (STANDARD). Primary outcome was patient satisfaction and HRQoL using validated questionnaires. Secondary outcomes were provider satisfaction, surgical site infection (SSI) rates, and wound complications.ResultsIn total, 160 women were randomized. Population characteristics were not significant among groups. RELIATECT dressing group had an overall higher score of satisfaction and HRQoL compared with STANDARD group. Women in the RELIATECT group reported less incision odor and incisional pain. Compared with the STANDARD group, most women in RELIATECT dressing group reported better daily activities, self-esteem, personal hygiene, body image, and sleep. Providers reported that the RELIATECT dressing allowed better assessment of the surgical incision site, allowed patients to shower early, and did observe less wound dressing leakage. No differences were found in other secondary end points.ConclusionPostcesarean RELIATECT dressing for wound care in pregnant women with obesity had better patient and provider satisfaction as well as better HRQoL scores. Further, level 1 evidence is needed to assess its impact on SSI rates and wound complication, as this trial was not powered to accomplish this goal.Key points· This study was conducted to evaluate RELIATECT on patient satisfaction and HRQoL following a cesarean.. · Post-cesarean RELIATECT dressing for wound care had better HRQoL and patient and provider satisfaction scores.. · This is the first randomized controlled trial evaluating RELIATECT dressing in obese pregnant women undergoing cesarean section..

Project description:Postoperative nausea and vomiting (PONV) is one of the most common adverse outcomes after strabismus surgery. The primary outcome of this prospective, randomized, double-blind study was to compare the incidences of nausea or vomiting, and patient satisfaction of ondansetron and ramosetron after strabismus surgery under general anesthesia. The secondary outcome was to investigate whether the number of involved extraocular muscles (EOMs) in strabismus surgery was related to PONV.One hundred and five patients (aged 18-60 years) undergoing strabismus surgery were allocated randomly to one of the three groups: placebo, ondansetron, or ramosetron. Patients received 2 ml placebo, 4 mg ondansetron, or 0.3 mg ramosetron at the end of surgery. Each of the three groups was subdivided into two subgroups according to the number of EOMs involved in the surgery: subgroup S, single-muscle correction; subgroup M, multiple-muscle correction. The incidences of nausea or vomiting, and patient satisfaction at 2, 24 and 48 h after surgery were analyzed as primary outcome. With regard to subgroups S and M in the placebo, ondansetron and ramosetron groups, incidences of nausea or vomiting, and patient satisfaction at 2, 24 and 48 h after surgery were analyzed as seconadary outcome.The incidence of nausea was significantly lower in the ramosetron group at 2 h (9.4 %) than in the placebo (45.2 %) and ondansetron (34.7 %) groups (P < 0.05). The incidence of nausea was also significantly lower in the ramosetron group at 24 h than in the other groups (P < 0.05). Patients in the ramosetron group were more satisfied at 2 h (8.11 ± 0.98) and 24 h (8.50 ± 0.67) after surgery than those in the other groups (P < 0.05). With regard to subgroups S and M in the placebo, ondansetron and ramosetron groups, there were no significant differences in either the incidence of nausea or patient satisfaction.Ramosetron has superior antiemetic activity to ondansetron in adult strabismus surgery patients. The number of EOMs involved in strabismus surgery was not related to the incidence of PONV.Clinical Research Information Service (CRiS) Identifier: KCT0000688 . Date of registration: 27 February 2013.

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A randomized trial of phenylephrine infusion versus bolus dosing for nausea and vomiting during Cesarean delivery in obese women.

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A randomized trial of phenylephrine infusion versus bolus dosing for nausea and vomiting during Cesarean delivery in obese women.

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