Effect of Propofol on Postoperative Nausea and Vomiting. ((PONV))
Primary Purpose
Postoperative Nausea and Vomiting
Status
Completed
Phase
Phase 4
Locations
Pakistan
Study Type
Interventional
Intervention
Propofol
saline 0.9%
Sponsored by
About this trial
This is an interventional other trial for Postoperative Nausea and Vomiting focused on measuring postoperative nausea and vomiting, propofol
Eligibility Criteria
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
Sites / Locations
- PAF Hospital Islamabad
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Propofol
Placebo
Arm Description
Subhypnotic dose of propofol, 0.5mg/kg, 10 - 15 min before end of surgery
Normal saline 0.9%, 10 mL , 10 - 15 min before end of surgery
Outcomes
Primary Outcome Measures
postoperative nausea and vomiting
Subjective complaint of nausea or any episode of vomiting
Secondary Outcome Measures
Full Information
NCT ID
NCT05071794
First Posted
September 28, 2021
Last Updated
January 28, 2023
Sponsor
Pakistan Air Force (PAF) Hospital Islamabad
1. Study Identification
Unique Protocol Identification Number
NCT05071794
Brief Title
Effect of Propofol on Postoperative Nausea and Vomiting.
Acronym
(PONV)
Official Title
Effect of Propofol on Postoperative Nausea and Vomiting in Patients Undergoing Elective Cesarean Section Under Spinal Anesthesia.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
October 29, 2021 (Actual)
Study Completion Date
October 29, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pakistan Air Force (PAF) Hospital Islamabad
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
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting
Keywords
postoperative nausea and vomiting, propofol
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Randomized clinical trial
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Propofol
Arm Type
Active Comparator
Arm Description
Subhypnotic dose of propofol, 0.5mg/kg, 10 - 15 min before end of surgery
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Normal saline 0.9%, 10 mL , 10 - 15 min before end of surgery
Intervention Type
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
propofol injection
Intervention Description
Antiemetic effect of propofol
Intervention Type
Drug
Intervention Name(s)
saline 0.9%
Other Intervention Name(s)
normal saline
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
postoperative nausea and vomiting
Description
Subjective complaint of nausea or any episode of vomiting
Time Frame
1 hour stay in Postanaesthesia Care Unit
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Biological
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ATIF NAZIR, MD
Organizational Affiliation
PAF Hospital Islamabad
Official's Role
Principal Investigator
Facility Information:
Facility Name
PAF Hospital Islamabad
City
Islamabad
State/Province
Federal
ZIP/Postal Code
44230
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30209576
Citation
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.
Results Reference
background
PubMed Identifier
27746521
Citation
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.
Results Reference
background
PubMed Identifier
32259138
Citation
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.
Results Reference
background
PubMed Identifier
24729843
Citation
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.
Results Reference
background
PubMed Identifier
28860857
Citation
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.
Results Reference
background
PubMed Identifier
31521119
Citation
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.
Results Reference
result
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Effect of Propofol on Postoperative Nausea and Vomiting.
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