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The Regain of Gastrointestinal Motility After General Anaesthesia Versus Spinal Anaesthesia in Caesarean Section

NCT02504749 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2016-02-01

No results posted yet for this study

Summary

This study aims to compare the time to regain intestinal motility after general anesthesia versus spinal anesthesia for cesarean section.

A double blinded randomized controlled trial was conducted at the Department of Obstetrics and Gynecology, Kasr El-Aini Teaching Hospital, Faculty of Medicine, Cairo University, Cairo, Egypt, between July 20 and November 20, 2015. In the study hospital, the total number of deliveries in 2012 was 15 167, 6244 (41.2%) of which were by cesarean; in 2013, the total number of deliveries was 16 057, 5200 (32.4%) of which were by cesarean.

Conditions

  • G.I.T. Motility After General Versus Spinal Anaesthesia

Interventions

PROCEDURE

general anasthesia,spinal anasthesia

Randomization done by computer generated random number in sealed opaque envolopes.Each patient was given a study information sheet and a consent was signed. Sample size was calculated to prevent type II error. Based on these data, we would need to study 225 cases in each arm to be able to reject the null hypothesis that the rates for the experimental and control groups are equal with a probability of 80%. The type I error probability associated with this test for the null hypothesis is 0.05. We used an uncorrected chi-squared statistic to evaluate this null hypothesis. Additionally, to compensate for discontinuations, we recruited 225 women in each arm. 450-pregnant women with an indication for caesarean section were randomly allocated .

Sponsors & Collaborators

  • Kasr El Aini Hospital

    lead OTHER

Principal Investigators

  • Kasr El Ainy · Office Dean

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02504749 on ClinicalTrials.gov