NCT Number: NCT07638527
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
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 4
Faisalābad, Punjab Province, 38000, Pakistan
Asifa Saeed, MBBS; FCPS
CONTACT
Asifa Saeed, MBBS; FCPS
PRINCIPAL_INVESTIGATOR
Huda Ather, MBBS
CONTACT
Huda Ather, MBBS
SUB_INVESTIGATOR
M. Ibtisam Ahmad, MBBS
SUB_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ondansetron 4 mg IV administered as a single colorless syringe 5-10 minutes before induction of anesthesia for prevention of postoperative nausea and vomiting.
Other names: Zofran, Zophren, Onmax
Dexamethasone 8 mg IV administered as a single colorless syringe 5-10 minutes before induction of anesthesia for prevention of postoperative nausea and vomiting.
Other names: Decadron, Oradexon, Fortecortin
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.
Other names: Maxolon, Reglan, Paspertin
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: First 24 hours after surgery
Total number of rescue antiemetic (metoclopramide 10 mg IV) doses administered to each patient within the first 24 hours.
Time frame: 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.
Time frame: From drug administration up to 24 hours post-surgery
Proportion of patients experiencing any adverse reaction including allergic reaction, headache, perineal burning, dystonia, or QT prolongation on post-operative ECG.
Contact information is provided by the study sponsor or research team.
Asifa Saeed, MBBS; FCPS
CONTACT
Huda Ather, MBBS
CONTACT
Faisalabad Medical University
Other
Time-to-first-rescue Antiemetic With Ondansetron Plus Metoclopramide Versus Dexamethasone Plus Metoclopramide for PONV Prophylaxis in Laparoscopic Cholecystectomy: a Randomized, Triple-Blind, Superiority Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07632833
Adolescent Idiopathic Scoliosis, Anxiety
View Trial DetailsNCT07451392
Delayed Gastric Emptying, Digestive System Diseases
View Trial DetailsNCT06060418
Nausea, Pathologic Processes
Sheikhupura, Punjab Province, Pakistan
View Trial DetailsNCT06546514
Anxiety Disorders, Mental Disorders
Erzurum, Palandöken, Turkey (Türkiye)
View Trial Details