- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06043336
Palonosetron vs Combination of Granisetron and Dexamethasone in Preventing PONV in Laparoscopic Cholecystectomy.
A Comparative Study Between Palonosetron vs the Combination of Granisetron and Dexamethasone in Preventing Postoperative Nausea and Vomiting in Laparoscopic Cholecystectomy.
This is a prospective, randomized, double-blinded study comparing the post-operative nausea vomiting (PONV) profile following administration of intraoperative palonosetron alone and the combination of granisetron and dexamethasone in moderate to high-risk patients undergoing elective laparoscopic cholecystectomy.
Patients aged 18-65 years with American Society of Anesthesiologists physical status I or II were randomized into two groups. Group A received 1 ml of intravenous (IV) 0.9% saline after intubation and IV palonosetron 0.075 mg at the end of operation. Group B received IV dexamethasone 4 mg after intubation and IV granisetron 1 mg at the end of surgery. The occurrence of PONV and the need for rescue antiemetics were assessed at 30 minutes, 4, 24 and 48 hours post-anesthesia. A complete response towards the study drugs was considered when patients did not experience PONV and did not require rescue antiemetics. The side effects of the study drugs were evaluated. Patient satisfaction with the anti-emetics administered was assessed.
These parameters were compared between Group A and Group B: the occurrence of PONV, the need of rescue antiemetics, the side effects of the study drugs and patient satisfaction with the anti-emetics administered.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This prospective double-blinded, randomized controlled study was conducted at Hospital Canselor Tuanku Muhriz, Universiti Kebangsaan Malaysia, Malaysia after obtaining approval from the Institutional Ethics Committee of Universiti Kebangsaan Malaysia (UKM).
Patients aged 18 to 65 years old, American Society of Anesthesiologists (ASA) physical status I or II, scheduled for elective laparoscopic cholecystectomy under general anesthesia were recruited using convenient sampling. Patients with heart diseases, prolonged QT syndrome, a family history of sudden death, known allergies, or contraindications to the study drugs were excluded. No premedication was administered to the patients, and an intravenous (IV) drip was not started preoperatively.
After obtaining written informed consent, patients were randomized to one of two groups using computer-generated random numbers. Group A received IV palonosetron 0.075 mg, and Group B received IV granisetron 1 mg and IV dexamethasone 4 mg as antiemetics.
Patients were fasted for at least 6 hours prior to surgery. In the operating room, standard monitoring was applied to every patient, including continuous electrocardiography (ECG), non-invasive blood pressure monitoring (NIBP), pulse oximetry, capnography with multi-gas analyzer including minimum alveolar concentration (MAC), and monitoring of all gas levels.
Patients were pre-oxygenated with oxygen. Induction of anesthesia was conducted using IV fentanyl 2 mcg/kg and IV propofol 2 mg/kg. Upon loss of consciousness, IV rocuronium 0.6 mg/kg was administered to facilitate endotracheal intubation, following which patients were mechanically ventilated with a mixture of oxygen and air. Anesthesia was maintained with sevoflurane at MAC of 1.0 to 1.2. Ventilation parameters were adjusted to maintain normocapnia (end-tidal carbon dioxide of 35-40 mmHg) and saturation of oxygen above 96%.
Group A patients received 1 ml of IV 0.9% saline while Group B patients received IV dexamethasone 4 mg after intubation. The amount of IV morphine given to the patients intraoperatively was recorded and did not exceed 0.1 mg/kg. Rescue analgesia with IV fentanyl was administered if needed, not exceeding 100 mcg. The surgeon infiltrated 10 ml of levobupivacaine 0.5% into the incisions at the end of surgery. Patients were kept adequately hydrated throughout the surgery with an IV drip of 2 ml/kg/h as maintenance, any fluid deficit was replaced. Pneumoperitoneum in laparoscopic procedure was achieved by carbon dioxide insufflation with intra-abdominal pressure of less than 14 mmHg.
Thirty minutes prior to the end of the surgery, Group A received a slow bolus of IV palonosetron 0.075 mg, while Group B received a slow bolus of IV granisetron 1 mg. Intravenous neostigmine 0.05 mg/kg and IV atropine 0.02 mg/kg were administered as a reversal agent. The pneumoperitoneum was evacuated by the surgeon, and the nasogastric tube was suctioned and removed before extubation. The patients were transferred to the recovery bay after extubation. Rescue analgesia with IV fentanyl was administered in the recovery bay if needed, not exceeding 50 mcg.
Patients were monitored by blinded anesthetists for nausea and vomiting in four time periods: 30 minutes, 4 hours, 24 hours, and 48 hours post-anesthesia. Nausea was defined as an unpleasant sensation associated with the urge to vomit and its severity was rated by patients on a scale of 0 (no nausea) to 10 (worst possible nausea). Vomiting was defined as the forceful expulsion of gastric contents from the mouth, and the frequency of vomiting was recorded. If a patient experienced severe nausea (nausea score of 4 and more) and vomiting, rescue antiemetic of IV metoclopramide 10 mg was administered. Regular IV metoclopramide was administered if the patient experienced a second episode of vomiting or more. A complete response (free from emesis) was defined as no nausea, no vomiting and no need for any rescue medication. Side effects of the study drugs (palonosetron, granisetron, and dexamethasone) such as headache, constipation, dizziness, bloatedness, and palpitation were recorded. At the end of the study, patients were asked if they were satisfied with the antiemetics given to them. Patient satisfaction was assessed by using a Likert scale, which included a five-point scale; very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. Surgeries that lasted more than four hours, required conversion to open cholecystectomy or other procedures, and severe PONV that did not resolve with rescue anti-emetics were considered dropouts in this study.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Kuala Lumpur
-
Cheras, Kuala Lumpur, Malaysia, 56000
- Hospital Canselor Tuanku Muhriz Universiti Kebangsaan Malaysia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- aged 18 to 65 years old
- American Society of Anesthesiologists (ASA) physical status I or II
- scheduled for elective laparoscopic cholecystectomy under general anesthesia
Exclusion Criteria:
- patients with heart diseases
- patients with prolonged QT syndrome
- patients with a family history of sudden death
- patients with known allergies to dexamethasone, granisetron & palonosetron
- patients with contraindications to dexamethasone, granisetron & palonosetron
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group B
Group B received intravenous (IV) dexamethasone 4 mg after intubation & IV granisetron 1 mg at the end of surgery
|
. Group A received 1 ml of intravenous (IV) 0.9% saline after intubation and IV palonosetron 0.075 mg at the end of operation.
Group B received IV dexamethasone 4 mg after intubation and IV granisetron 1 mg at the end of surgery
|
Experimental: Group A
Group A received 1 ml of intravenous (IV) 0.9% saline after intubation and IV palonosetron 0.075 mg at the end of operation.
|
. Group A received 1 ml of intravenous (IV) 0.9% saline after intubation and IV palonosetron 0.075 mg at the end of operation.
Group B received IV dexamethasone 4 mg after intubation and IV granisetron 1 mg at the end of surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complete response towards the study drugs
Time Frame: 1 year
|
Number of patients who did not experience postoperative vomiting, did not experience postoperative nausea & did not require rescue antiemetics.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The side effects of the study drugs
Time Frame: 1 year
|
Number of patients who developed side effects after receiving the study drugs
|
1 year
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient satisfaction with the anti-emetics administered
Time Frame: 1 year
|
Number of patients who satisfied with the anti-emetics administered
|
1 year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Maryam Budiman, M.D., Faculty of Medicine, Universiti Kebangsaan Malaysia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Signs and Symptoms, Digestive
- Nausea
- Vomiting
- Postoperative Nausea and Vomiting
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Serotonin Agents
- Serotonin Antagonists
- Serotonin 5-HT3 Receptor Antagonists
- Dexamethasone
- Palonosetron
- Granisetron
Other Study ID Numbers
- FF-2018-209
- Fundamental data (Other Identifier: Universiti Kebangsaan Malaysia, Malaysia)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on Postoperative Nausea and Vomiting
-
Cukurova UniversityTarsus UniversityRecruitingNausea, Postoperative | Vomiting, Postoperative | APFEL RİSK SCORETurkey
-
Methodist Health SystemRecruitingNausea, Postoperative | Vomiting, PostoperativeUnited States
-
GlaxoSmithKlineCompletedPostoperative Nausea and Vomiting | Nausea and Vomiting, PostoperativeUnited States, Spain, Philippines, Israel, Hong Kong, Thailand, United Kingdom, Hungary, Slovenia, Norway, Denmark
-
MonoSol RxCompletedNausea With Vomiting Chemotherapy-Induced | Nausea and Vomiting, PostoperativeIndia
-
Yeungnam University College of MedicineCompletedPostoperative Nausea | Postoperative VomitingKorea, Republic of
-
Northwell HealthTerminatedPostoperative Pain | Postoperative Nausea | Postoperative VomitingUnited States
-
Hôpital Privé de Parly II - Le ChesnayCompletedPostoperative Nausea | Postoperative Vomiting | Postoperative EmesisFrance
-
Vestre VikenHF Kongsberg SykehusNorwegian Medical AssociationCompletedPostoperative Complications | Postoperative Pain | Postoperative Vomiting and Nausea | Mental Status Changes PostoperativeKazakhstan, Russian Federation
-
Oregon Health and Science UniversityCompletedPostoperative Vomiting and NauseaUnited States
-
GlaxoSmithKlineCompletedPostoperative Nausea and Vomiting | Nausea and Vomiting, PostoperativeUnited States, Hungary, Canada, Spain, Belgium, Germany
Clinical Trials on Dexamethasone, granisetron & palonosetron
-
Taiho Pharmaceutical Co., Ltd.CompletedChemotherapy-Induced Nausea and VomitingJapan
-
Joseph RoscoeNational Cancer Institute (NCI)Completed
-
Xijing HospitalCompletedChemotherapy-Induced Nausea and VomitingChina
-
Wuhan Union Hospital, ChinaUnknownChemotherapy-induced Nausea and Vomiting
-
Helsinn Healthcare SAActive, not recruitingChemotherapy-induced Nausea and VomitingSpain, Germany, Switzerland, China, Czechia, United Kingdom, Greece
-
Fudan UniversityNot yet recruitingChemotherapy-induced Nausea and Vomiting (CINV)
-
Guangxi Medical UniversityNot yet recruiting
-
Azienda Ospedaliera di PerugiaUnknown
-
Helsinn Healthcare SAThe Physicians' Services Incorporated Foundation; George Clinical Pty LtdCompletedChemotherapy-induced Nausea and VomitingUnited States, Georgia
-
NYU Langone HealthEisai Inc.Completed