NCT05071794

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 8, 2021

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 29, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 29, 2022

Completed
Last Updated

January 31, 2023

Status Verified

January 1, 2023

Enrollment Period

6 months

First QC Date

September 28, 2021

Last Update Submit

January 28, 2023

Conditions

Postoperative Nausea and Vomiting

Keywords

postoperative nausea and vomiting, propofol

Outcome Measures

Primary Outcomes (1)

  • postoperative nausea and vomiting

    Subjective complaint of nausea or any episode of vomiting

    1 hour stay in Postanaesthesia Care Unit

Study Arms (2)

Propofol

ACTIVE COMPARATOR

Subhypnotic dose of propofol, 0.5mg/kg, 10 - 15 min before end of surgery

Drug: Propofol

Placebo

PLACEBO COMPARATOR

Normal saline 0.9%, 10 mL , 10 - 15 min before end of surgery

Drug: saline 0.9%

Interventions

PropofolDRUG

Antiemetic effect of propofol

Also known as: propofol injection
Propofol
saline 0.9%DRUG

Placebo

Also known as: normal saline
Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsBiological
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PAF Hospital Islamabad

Islamabad, Federal, 44230, Pakistan

Location

Related Publications (6)

  • Niu K, Liu H, Chen RW, Fang QW, Wen H, Guo SM, Williams JP, An JX. Use of propofol for prevention of post-delivery nausea during cesarean section: a double-blind, randomized, placebo-controlled trial. J Anesth. 2018 Oct;32(5):748-755. doi: 10.1007/s00540-018-2549-x. Epub 2018 Sep 12.

    PMID: 30209576BACKGROUND

  • Shaikh SI, Nagarekha D, Hegade G, Marutheesh M. Postoperative nausea and vomiting: A simple yet complex problem. Anesth Essays Res. 2016 Sep-Dec;10(3):388-396. doi: 10.4103/0259-1162.179310.

    PMID: 27746521BACKGROUND

  • Urits I, Orhurhu V, Jones MR, Adamian L, Borchart M, Galasso A, Viswanath O. Postoperative Nausea and Vomiting in Paediatric Anaesthesia. Turk J Anaesthesiol Reanim. 2020 Apr;48(2):88-95. doi: 10.5152/TJAR.2019.67503. Epub 2019 Nov 11.

    PMID: 32259138BACKGROUND

  • Kim EG, Park HJ, Kang H, Choi J, Lee HJ. Antiemetic effect of propofol administered at the end of surgery in laparoscopic assisted vaginal hysterectomy. Korean J Anesthesiol. 2014 Mar;66(3):210-5. doi: 10.4097/kjae.2014.66.3.210. Epub 2014 Mar 28.

    PMID: 24729843BACKGROUND

  • Jelting Y, Klein C, Harlander T, Eberhart L, Roewer N, Kranke P. Preventing nausea and vomiting in women undergoing regional anesthesia for cesarean section: challenges and solutions. Local Reg Anesth. 2017 Aug 9;10:83-90. doi: 10.2147/LRA.S111459. eCollection 2017.

    PMID: 28860857BACKGROUND

  • Kampo S, Afful AP, Mohammed S, Ntim M, Buunaaim ADB, Anabah TW. Sub-hypnotic dose of propofol as antiemetic prophylaxis attenuates intrathecal morphine-induced postoperative nausea and vomiting, and pruritus in parturient undergoing cesarean section - a randomized control trial. BMC Anesthesiol. 2019 Sep 14;19(1):177. doi: 10.1186/s12871-019-0847-y.

    PMID: 31521119RESULT

MeSH Terms

Conditions

Postoperative Nausea and VomitingVomiting

Interventions

PropofolSodium ChlorideSaline Solution

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and Symptoms

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • ATIF NAZIR, MD

    PAF Hospital Islamabad

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Randomized clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Registrar Anesthesiologist

Study Record Dates

First Submitted

September 28, 2021

First Posted

October 8, 2021

Study Start

May 1, 2021

Primary Completion

October 29, 2021

Study Completion

October 29, 2022

Last Updated

January 31, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)