Preoperative Oral Carbohydrate for Nausea and Vomiting Prevention During Cesarian Section (POC-NaVoP)

September 14, 2020 updated by: Katarzyna Kotfis, Pomeranian Medical University Szczecin

An Analysis of Risk Factors and Implementation of Strategies to Prevent Nausea and Vomiting in Patients Undergoing Regional Anesthesia for Caesarean Section

Post-operative nausea and vomiting (PONV) in women undergoing subarachnoid anesthesia for Caesarean section is an important clinical problem. The aim of this study is to compare the effectiveness of oral carbohydrate loading to standard pre-operative fasting in patients undergoing elective cesarean section on the incidence and severity of PONV and biochemical parameters indicating ketosis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Post-operative nausea and vomiting (PONV) in women undergoing subarachnoid anesthesia for Caesarean section is an important clinical problem. Known mechanisms underlying PONV are based on prolonged fasting, hypotension due to concomitant sympatholysis during anesthesia, bradycardia due to increased vagal tone, visceral stimulation during surgery and intrathecal administered opioids. However, the identification of patients exposed to this problem and appropriate perioperative preparation is of key importance. An analysis of risk factors for postoperative nausea and vomiting in patients undergoing elective cesarean section under spinal anesthesia is of major clinical importance. The aim of this study is a comparison of the effectiveness of oral carbohydrate loading strategy as compared with standard pre-operative fasting in patients undergoing elective cesarean section under spinal anesthesia on the incidence and severity of PONV and biochemical parameters indicating ketosis.

Study Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Not Applicable

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

  • Poland
      • Szczecin, Poland, 70-111
        • Recruiting
        • Pomeranian Medical University
        • Contact:

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Age >=18 years.
  2. Scheduled for an elective cesarean section.
  3. Uncomplicated pregnancy.
  4. Planned for spinal anesthesia.
  5. ASA I or ASA II.

Exclusion Criteria:

  1. History of diabetes.
  2. History of gastro-intestinal reflux (GERD).
  3. Unable or unwilling to sign an informed consent.
  4. Contraindications to spinal anesthesia.
  5. Contraindication to Oral carbohydrate formula.

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Preoperative oral carbohydrate load
6 hours for solid food and 2 hours for liquids + oral carbohydrate preparation 2 hours prior to surgery.
Dietary supplement: preoperative oral carbohydrate, preOp
Patients in the experimental arm will receive oral carbohydrate preparation at 2 hours prior to planned caesarian section.
No Intervention: Standard preoperative fasting
6 hours for solid food and 2 hours for liquids.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative nausea and vomiting 6 hours after caesarian section.
Time Frame: 6 hours
The Postoperative Nausea and Vomiting (PONV) Intensity Scale 6 hours after caesarian section. Scale range: 0-50. The scale measures PONV intensity, where a score ≥50 defined clinically important PONV: PONV Intensity Scale=severity of nausea (1=mild, 2=moderate, 3=severe)×pattern of nausea (1=varying, 2=constant)×duration of nausea (in hours).
6 hours
Postoperative nausea and vomiting 24 hours after caesarian section.
Time Frame: 24 hours
The Postoperative Nausea and Vomiting (PONV) Intensity Scale 24 hours after caesarian section. Scale range: 0-50. The scale measures PONV intensity, where a score ≥50 defined clinically important PONV: PONV Intensity Scale=severity of nausea (1=mild, 2=moderate, 3=severe)×pattern of nausea (1=varying, 2=constant)×duration of nausea (in hours).
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first peristalsis.
Time Frame: 24 hours
Moment of first peristalsis after operation (in hours).
24 hours
Time to first bowel movement.
Time Frame: 24 hours
Moment of first bowel movement after operation (in hours).
24 hours
Concentration of serum lactate in serum.
Time Frame: 0 hours
Lactate level measured in maternal serum.
0 hours
Concentration of beta-hydroxy-butiric acid in serum.
Time Frame: 0 hours
Beta-hydroxy-butiric acid level measured in maternal serum.
0 hours
Insulin resistance factor (HOMA-IR).
Time Frame: 0 hours
Insulin resistance measured in maternal serum.
0 hours
Concentration of isoprostane in urine.
Time Frame: 0 hours
Isoprostane level measured in maternal urine.
0 hours

Collaborators and Investigators

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

Sponsor

Pomeranian Medical University Szczecin

Investigators

  • Principal Investigator: Katarzyna L Kotfis, MD, PhD, Pomeranian Medical University
  • Study Chair: Sebastian Kwiatkowski, MD, PhD, Pomeranian Medical University

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)

September 3, 2019

Primary Completion (Anticipated)

March 31, 2021

Study Completion (Anticipated)

August 31, 2021

Study Registration Dates

First Submitted

August 23, 2019

First Submitted That Met QC Criteria

August 26, 2019

First Posted (Actual)

August 28, 2019

Study Record Updates

Last Update Posted (Actual)

September 16, 2020

Last Update Submitted That Met QC Criteria

September 14, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PUM_08.08.2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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.

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