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Variable versus fixed-rate infusion of phenylephrine during cesarean delivery: a randomized controlled trial.

ABSTRACT: 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.

SUBMITTER: Hasanin A

PROVIDER: S-EPMC6827237 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

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Variable versus fixed-rate infusion of phenylephrine during cesarean delivery: a randomized controlled trial.

Hasanin Ahmed A Habib Sara S Abdelwahab Yaser Y Elsayad Mohamed M Mostafa Maha M Zayed Marwa M Kamel Mohamed Maher MM Hussein Kareem K Refaat Sherin S Fouda Ahmed Y AY Wali Ahmed A AA Elshafaei Khaled A KA Mahmoud Doaa D Amin Sarah S

BMC anesthesiology 20191103 1

<h4>Background</h4>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 prop ...[more]

PMID: 31679509

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Project description:Oxytocin is routinely used as prophylaxis against uterine atony. During elective cesarean delivery (CD), an oxytocin bolus is used to initiate adequate uterine tone, followed by an oxytocin infusion to maintain uterine contractility. However, it is unclear whether oxytocin maintenance infusion rate influences total estimated blood loss (EBL).We performed a prospective, randomized, double-blind trial in 51 women undergoing elective CD. Women were randomly assigned to receive an oxytocin maintenance infusion of 2.5 or 15 U/h. All women received an oxytocin 1 U bolus to initiate adequate uterine tone. The primary outcome was EBL. EBL values between groups were compared using a Mann-Whitney U test; P < .05 as statistically significant. The median EBL difference with 95% confidence intervals was also calculated. Secondary outcomes included adequacy of uterine tone, use of additional uterotonics, and oxytocin-related side effects, including hypotension.Of 51 women, 24 received a low-rate infusion and 27 received a high-rate infusion. Median (interquartile range) EBL values in the low-rate and high-rate groups were 634 (340-886) mL versus 512 (405-740) mL, respectively (P = .7). The median difference in EBL between groups was 22 mL; 95% confidence interval = -158 to 236 mL. The rate of postpartum hemorrhage did not differ between groups (low-rate group: 4/24 [16.7%] versus high-rate group: 4/26 [15.4%]). There were no between-group differences over time (first 20 minutes after commencing infusion) in the incidence of adequate uterine tone (P = .72) or hypotension (P = .32).Among women undergoing elective CD receiving an oxytocin maintenance infusion, EBL and uterine tone did not differ between women receiving 2.5 U/h oxytocin and those receiving 15 U/h oxytocin. Our findings suggest that efficacy can be obtained with a low oxytocin maintenance infusion rate; however, dose-finding studies are needed to determine the infusion rate that optimizes drug efficacy while minimizing side effects.

Project description:BackgroundThe effect of maternal amino acid (AA) infusion before and during cesarean delivery on neonatal temperature remains unknown. We hypothesized that thermogenic effects of AA metabolism would help maintain body temperature of newborn babies and their mothers.MethodsSeventy-six parturients scheduled for elective singleton term cesarean delivery were equally randomized to receive intravenous 200 ml of AA or placebo approximately 1 h before subarachnoid block (infusion rate:100 ml/h). The primary outcome was the newborn rectal temperature at 0, 5 and 10 min after birth. The secondary outcomes included the maternal rectal temperature at six time-points: T0 = before starting study solution infusion, T1 = 30 min after starting infusion, T2 = one hour after starting infusion, T3 = during spinal block, T4 = half an hour after spinal block, T5 = at the time of birth and T6 = at the end of infusion, as well as maternal thermal discomfort and shivering episodes.ResultsThere were no differences in newborn temperature between the two groups at any of the time-points (intervention-time-interaction effect, P = 0.206). The newborn temperature (mean [95%CI] °C) at birth was 37.5 [37.43-37.66] in the AA and 37.4 [37.34-37.55] in the placebo group. It showed a significant (P < 0.001) downward trend at 5 and 10 min after birth (time effect) in both groups. One neonate in the AA and five in the placebo group were hypothermic (temperature < 36.5 °C) (P = 0.20). There was a significant difference in the maternal temperature at all time points between the two groups (Intervention-time interaction effect, P < 0.001). However, after adjustment for multiplicity, the difference was significant only at T6 (P = 0.001). The mean difference [95%CI] in temperature decline from baseline (T0) till the end of infusion (T6) between the two groups was - 0.39 [- 0.55;- 0.22] °C (P < 0.0001). Six mothers receiving placebo and none receiving AA developed hypothermia (temperature < 36 °C) (P = 0.025). Maternal thermal discomfort and shivering episodes were unaffected by AA therapy.ConclusionsUnder the conditions of this study, maternal AA infusion before and during spinal anesthesia for cesarean delivery did not influence the neonatal temperature within 10 min after birth. In addition, the maternal temperature was only maintained at two hours of AA infusion.Trial registrationClinicalTrials.government, Identifier NCT02575170 . Registered on 10th April, 2015 - Retrospectively registered.

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..

Dataset Information

Variable versus fixed-rate infusion of phenylephrine during cesarean delivery: a randomized controlled trial.

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Variable versus fixed-rate infusion of phenylephrine during cesarean delivery: a randomized controlled trial.

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