Effect of Propofol on Postoperative Nausea and Vomiting. ((PONV))

January 28, 2023 updated by: Atif Nazir, Pakistan Air Force (PAF) Hospital Islamabad

Effect of Propofol on Postoperative Nausea and Vomiting in Patients Undergoing Elective Cesarean Section Under Spinal Anesthesia.

As PONV is an unpleasant experience that badly affects the patients' quality of life after surgery and the anti-emetic effects of propofol have been seldomly studied in Pakistan, this study aims at investigation of the beneficial effects of propofol in reducing the occurrence of PONV.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cesarean Section is one of the most commonly performed surgical procedures in the obstetric patients. Adequate intra and postoperative analgesia is very important in providing comfort to the mother, early breastfeeding, ambulation and discharge as well as enhancing patient satisfaction.Spinal anesthesia is widely accepted as the anesthesia of choice for cesarean section owing to its safety and speed. PONV is an unpleasant condition, often underestimated side effect of anesthesia and surgery, quite common in women undergoing spinal anesthesia for cesarean.It is one of the significant problems in Post Anaesthesia Care Units. The etiology of PONV is multifactorial with patient factors (gender, history of motion sickness, age), intra Op factors (type of anesthesia, surgery and opioid use) and post Op factors (pain, post Op opioid use) which are found to be associated with the PONV. Apfel simplified scoring is based on four independent factors including female gender, non-smoker, history of PONV or motion sickness and use of opioids. Each predictor is given a score of 1. A score of 0,1,2,3 or 4 predicts the chance of developing PONV as approximately 10%, 20%, 40% or 80%.

The intense efforts accompanying emesis increase the risk of complications such as wound dehiscence, bleeding, aspiration pneumonitis, dehydration, electrolyte imbalance and interference with nutrition. While it is difficult to completely avoid the occurrence of PONV, it can be markedly reduced using a multimodal non-opioid analgesia, total intravenous anesthesia and adequate prophylactic antiemetic premedication. Propofol has been reported to have anti-emetic effects at sub hypnotic dose as a bolus or a continuous infusion in susceptible individuals undergoing surgeries, though the exact mechanism of this effect is yet to be discovered.

In a research published in BMC Anesthesiology, the data indicates a significant difference in the incidence of PONV in control group (93.9%) and the study group (8.7%) with a single sub hypnotic dose of propofol administered 10-15 min before the end of surgery in parturients undergoing cesarean section under spinal anaesthesia.

Study Type

Interventional

Enrollment (Actual)

60

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

  • Pakistan
    • Federal
      • Islamabad, Federal, Pakistan, 44230
        • PAF Hospital Islamabad

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 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Parturient aged between 18 - 50 years
  • Elective Cesarean under spinal anesthesia
  • Patients at increased risk of PONV based on Apfel score 2 or more
  • ASA Class II
  • Ability to give informed consent

Exclusion Criteria:

  • Allergy to propofol
  • ASA Class III and above
  • Anti emetic drug administered 24 hrs prior to surgery

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Propofol
Subhypnotic dose of propofol, 0.5mg/kg, 10 - 15 min before end of surgery
Drug: Propofol
Antiemetic effect of propofol
Other Names:
  • propofol injection
Placebo Comparator: Placebo
Normal saline 0.9%, 10 mL , 10 - 15 min before end of surgery
Drug: saline 0.9%
Placebo
Other Names:
  • normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative nausea and vomiting
Time Frame: 1 hour stay in Postanaesthesia Care Unit
Subjective complaint of nausea or any episode of vomiting
1 hour stay in Postanaesthesia Care Unit

Collaborators and Investigators

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

Sponsor

Pakistan Air Force (PAF) Hospital Islamabad

Investigators

  • Principal Investigator: ATIF NAZIR, MD, PAF Hospital Islamabad

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)

May 1, 2021

Primary Completion (Actual)

October 29, 2021

Study Completion (Actual)

October 29, 2022

Study Registration Dates

First Submitted

September 28, 2021

First Submitted That Met QC Criteria

September 28, 2021

First Posted (Actual)

October 8, 2021

Study Record Updates

Last Update Posted (Actual)

January 31, 2023

Last Update Submitted That Met QC Criteria

January 28, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAFHIslamabad

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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