Postoperative Nausea and Vomiting
Conditions
Keywords
PONV, Postoperative emesis, Postoperative nausea, Postoperative vomiting
Brief summary
The goal of this superiority randomized controlled trial (RCT) is to learn if one dual-drug arm increases patient comfort (time to needing rescue medication for nausea/vomiting) more effectively than the other in adults with Moderate-to-High PONV risk (Apfel score 2-4) undergoing elective laparoscopic cholecystectomy (gallbladder surgery). The main question this study aims to answer is: • Does Ondansetron plus Metoclopramide prolong time to first rescue antiemetic more than Dexamethasone plus Metoclopramide? Researchers will compare Group A (Ondansetron 4mg plus Metoclopramide 10mg IV) to Group B (Dexamethasone 8mg IV plus Metoclopramide 10mg IV) to see if Group A provides a longer time to first rescue medication. Participants will: * Receive their assigned, blinded drug group 5-10 minutes before general anesthesia induction. * Receive rescue Metoclopramide 10mg IV if they experience any vomiting or severe nausea * Be monitored for 24 hours post-surgery in the hospital * Report nausea severity at 2, 6, 12 and 24 hours post-surgery
Interventions
DRUGondansetron 4 mg
Ondansetron 4 mg IV administered as a single colorless syringe 5-10 minutes before induction of anesthesia for prevention of postoperative nausea and vomiting.
Dexamethasone 8 mg IV administered as a single colorless syringe 5-10 minutes before induction of anesthesia for prevention of postoperative nausea and vomiting.
Metoclopramide 10 mg IV administered as a single colorless syringe 5-10 minutes before induction of anesthesia as part of dual-agent PONV prophylaxis. Also used as rescue antiemetic (10 mg IV) if patient has vomiting or VRS \>4 for nausea.
Sponsors
Faisalabad Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * American Society of Anesthesiologists (ASA) physical status I or II * Scheduled for elective laparoscopic cholecystectomy * Apfel score 2-4 (moderate to high risk for PONV) * Provides written informed consent prior to enrollment
Exclusion criteria
* Known allergy or hypersensitivity to ondansetron, dexamethasone, or metoclopramide * Emergency surgery (e.g., acute cholecystitis, perforation, or gangrene) * Pregnancy or breastfeeding * ASA physical status III or IV * Preexisting hepatic impairment * Baseline corrected QT (QTc) interval \> 420 ms on pre-operative ECG * History of dystonic reaction to metoclopramide or other dopamine antagonists * Preexisting renal impairment (e.g., serum creatinine \> 1.5 mg/dL or on dialysis) * Unable or unwilling to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Rescue Antiemetic (in minutes) | First 24 hours after surgery (measured from the time of arrival to Post-anaesthesia care unit, PACU) | Time in minutes from patient arrival to Post-anaesthesia care unit, PACU (time zero) to administration of rescue metoclopramide 10 mg IV. Rescue is given if patient experiences any episode of vomiting/retching or reports a nausea Verbal Rating Scale (VRS) score \>4. VRS scale is no nausea (0), mild (1-3), moderate (4-6), and severe (7-10). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of PONV | 24 hours post-surgery | Proportion of patients experiencing any nausea (VRS \>1) or any vomiting/retching episode within the first 24 hours post-surgery. Verbal Rating Scale (VRS) is a well established measurement scale with a total of 11 points where 0 = no nausea and 10 = worst possible nausea. |
| Severity of Postoperative Nausea and Vomiting (RINVR Score) | Measured at 2, 6, 12, and 24 hours post-surgery | Measured using the Rhodes Index of Nausea, Vomiting, and Retching (RINVR). It evaluates 8 dimensions: frequency/duration/distress of nausea; frequency/amount/distress of vomiting; and frequency/distress of retching. Total score range is 0-32, with 0 indicating no nausea, 1-8 mild, 9-16 moderate, 17-24 severe, and 25-32 great nausea. The higher scores indicate worse PONV. |
| Number of Rescue Doses Required | First 24 hours after surgery | Total number of rescue antiemetic (metoclopramide 10 mg IV) doses administered to each patient within the first 24 hours. |
| Patient Satisfaction with Antiemetic Treatment | At hospital discharge (approximately 24 hours post-surgery) | Patient-reported satisfaction measured on a 5-point Likert scale (Very Dissatisfied to Very Satisfied) at the end of hospital stay. Likert scale is a 5-point psychometric survey scale, with 1 indicating very disappointing and 5 indicating very satisfying. The higher the score, the better the treatment was. |
Countries
Pakistan
Contacts
CONTACTAsifa Saeed, MBBS; FCPS
CONTACTHuda Ather, MBBS
PRINCIPAL_INVESTIGATORAsifa Saeed, MBBS; FCPS
Faisalabad Medical University
Outcome results
None listed