Antibiotic Prophylaxis and Nausea and Vomiting in Cesarean Section Under Regional Anesthesia.

January 5, 2021 updated by: Bahattin Tuncali, Baskent University Ankara Hospital

The Effect of Antibiotic Prophylaxis Timing on Intraoperative Nausea and Vomiting in Patients Undergoing Cesarean Section Under Regional Anesthesia.

The incidence of intraoperative nausea and vomiting in patients who undergo caesarean section (C/S) under regional anesthesia is approximately 30-80%. Hypotension, pain, visceral manipulation, fundal pressure, removal of the uterus during repair, intra-abdominal irrigation, central neural opioids, intravenous oxytocin and antibiotics are possible risk factors. Oxytocin and prophylactic antibiotics are administered simultaneously during C/S operation, especially after the umbilical cord is clamped. Simultaneous administration of drugs such as oxytocin and prophylactic antibiotics may induce nausea and vomiting after umbilical cord clamping in the patient. In this study, it was aimed to investigate the effect of prophylactic antibiotic administration 30 minutes before the incision and after cord clamping on intraoperative nausea and vomiting in patients undergoing elective C/S under regional anesthesia.

This study was planned to be carried out in Başkent University Zübeyde Hanım Research Center Operating Room with 120 pregnant women (≥ 37 gestational weeks) undergoing elective C/S under regional anesthesia in a prospective, randomized, double-blind manner.

Group 1 (Prophylactic antibiotic 30 minutes before skin incision): Antibiotic diluted in 10 ml syringe 30 minutes before skin incision and after cord clamping, 0.9% NaCl in 10 ml syringe will be administered intravenously within 15 seconds.

Group 2 (prophylactic antibiotic after cord clamping): 30 minutes before the skin incision, 0.9% NaCl in a 10 ml injector and after the cord is clamped, the antibiotic diluted in a 10 ml syringe will be administered intravenously within 15 seconds.

Intraoperative nausea-retching-vomiting episodes (0 = No symptoms, 1: Nausea (uncomfortable feeling with vomiting), 2: Gag (vomiting effort in which gastric contents cannot be expelled), 3: Vomiting (Gastric contents are forced by mouth. ejection)] will be recorded. Nausea scores will be evaluated on the verbal analog scale (VAS) with 11 points (0 = no nausea, 10 = the most severe nausea). Before anesthesia, all patients will be informed about the verbal analog scale (VAS) for nausea. VAS 1-3 = Mild Nausea, VAS 4-6 = Moderate nausea, VAS 7-10 = Severe nausea. Evaluations will be made at certain time intervals.

Before CSEA application Time interval between CSEA application and fetus discharge Time interval between fetus exit and expulsion of the uterus Time interval between expulsion of the uterus and insertion into the abdomen Time interval between insertion of the uterus in the abdomen and closing the fascia Time interval between fascia closure and skin closure Time interval between skin closure and patient transport to the recovery unit Nausea-retching-vomiting episodes, current systolic/diastolic blood pressure values, nausea-vomiting scores, antiemetic and / or ephedrine requirement, amount of intravenous fluid infused will be recorded.

Intraoperative prophylactic antibiotic use is considered as one of the possible causes of intraoperative nausea and vomiting in patients who underwent cesarean section under regional anesthesia. We believe that the results of our study can make contribution on both intraoperative nausea-vomiting etiology in cases undergoing cesarean section under regional anesthesia and the steps that can be taken to prevent it.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Recruiting
        • Baskent University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Pregnant women (≥ 37 gestational weeks) undergoing elective C/S under regional anesthesia

Exclusion Criteria:

  • Emergency C/S cases
  • Patients who had nausea before C/S
  • Patients who used antiemetics within 24 hours before C/S
  • Patients who have a history of smoking, postoperative nausea-vomiting, motion sickness, and hyperemesis before C/S
  • Patients with history of diabetes, morbid obesity (Body Mass Index> 40) and gastrointestinal disease
  • Psychiatric disorders
  • Patients who are allergic to the drugs to be used in the study
  • Patients for whom regional anesthesia is contraindicated

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Group 1
Group 1 (Prophylactic antibiotic 30 minutes before skin incision): Antibiotic diluted in 10 ml syringe 30 minutes before skin incision and after cord clamping, 0.9% NaCl in 10 ml syringe will be administered intravenously within 15 seconds.
Drug: Antibiotic prophylaxis timing (before skin incision and after cord clamping) for caesarean section
ACTIVE_COMPARATOR: Group 2
Group 2 (prophylactic antibiotic after cord clamping): 30 minutes before the skin incision, 0.9% NaCl in a 10 ml injector and after the cord is clamped, the antibiotic diluted in a 10 ml syringe will be administered intravenously within 15 seconds.
Drug: Antibiotic prophylaxis timing (before skin incision and after cord clamping) for caesarean section

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative nausea-retching-vomiting episodes
Time Frame: Intraoperative
0 = No symptoms, 1: Nausea (uncomfortable feeling with vomiting), 2: Gag (vomiting effort in which gastric contents cannot be expelled), 3: Vomiting (Gastric contents are forced by mouth. ejection)
Intraoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nausea score
Time Frame: Intraoperative
Nausea score will be evaluated on the verbal analog scale (VAS) with 11 points (0 = no nausea, 10 = the most severe nausea). Before anesthesia, all patients will be informed about the verbal analog scale (VAS) for nausea. VAS 1-3 = Mild Nausea, VAS 4-6 = Moderate nausea, VAS 7-10 = Severe nausea.
Intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baskent University Ankara Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 20, 2015

Primary Completion (ANTICIPATED)

April 30, 2021

Study Completion (ANTICIPATED)

May 30, 2021

Study Registration Dates

First Submitted

January 5, 2021

First Submitted That Met QC Criteria

January 5, 2021

First Posted (ACTUAL)

January 6, 2021

Study Record Updates

Last Update Posted (ACTUAL)

January 6, 2021

Last Update Submitted That Met QC Criteria

January 5, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KA15/197

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Intraoperative Nausea-retching-vomiting Episodes

Clinical Trials on Antibiotic prophylaxis timing (before skin incision and after cord clamping) for caesarean section

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Rwanda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe