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

Primary Purpose

Intraoperative Nausea-retching-vomiting Episodes, Nausea Scores Will be Evaluated on the Verbal Analog Scale (VAS)

Status
Unknown status
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Antibiotic prophylaxis timing (before skin incision and after cord clamping) for caesarean section
Sponsored by
Baskent University Ankara Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intraoperative Nausea-retching-vomiting Episodes focused on measuring antibiotic prophylaxis, nausea, vomiting, cesarean section, egional anesthesia

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Baskent UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group 1

Group 2

Arm Description

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Nausea score
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.

Full Information

First Posted
January 5, 2021
Last Updated
January 5, 2021
Sponsor
Baskent University Ankara Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04697277
Brief Title
Antibiotic Prophylaxis and Nausea and Vomiting in Cesarean Section Under Regional Anesthesia.
Official Title
The Effect of Antibiotic Prophylaxis Timing on Intraoperative Nausea and Vomiting in Patients Undergoing Cesarean Section Under Regional Anesthesia.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 20, 2015 (Actual)
Primary Completion Date
April 30, 2021 (Anticipated)
Study Completion Date
May 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baskent University Ankara Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraoperative Nausea-retching-vomiting Episodes, Nausea Scores Will be Evaluated on the Verbal Analog Scale (VAS)
Keywords
antibiotic prophylaxis, nausea, vomiting, cesarean section, egional anesthesia

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
A computer-generated random numbers table and sealed envelopes will be used to ensure randomization. The gynecologist performing the surgery, the anesthesiologist and the patients will not know the Group allocation. The medications will be prepared by the anesthesia technician responsible for the study. Prophylactic antibiotic and placebo will be prepared in 10 ml in the syringe and labeled as study drug.
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Antibiotic prophylaxis timing (before skin incision and after cord clamping) for caesarean section
Primary Outcome Measure Information:
Title
Intraoperative nausea-retching-vomiting episodes
Description
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)
Time Frame
Intraoperative
Secondary Outcome Measure Information:
Title
Nausea score
Description
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.
Time Frame
Intraoperative

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant women undergoing C/S under regional anesthesia
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bahattin Tuncali
Phone
+90 232 2411000
Email
tuncali.bahattin@gmail.com
Facility Information:
Facility Name
Baskent University
City
Ankara
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bahattin Tuncali
Phone
+90 232 2411000
Email
tuncali.bahattin@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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Antibiotic Prophylaxis and Nausea and Vomiting in Cesarean Section Under Regional Anesthesia.

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