Palonosetron vs Combination of Granisetron and Dexamethasone in Preventing PONV in Laparoscopic Cholecystectomy.

NCT06043336 | Completed Phase 4 DMC FDA Drug

• 2 other identifiers: FF-2018-209Fundamental data
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

• Complete response towards the study drugs

  Number of patients who did not experience postoperative vomiting, did not experience postoperative nausea \& did not require rescue antiemetics.

  1 year

Secondary Outcomes (1)

• The side effects of the study drugs

  1 year

Other Outcomes (1)

• Patient satisfaction with the anti-emetics administered

  1 year

Study Arms (2)

Group B

ACTIVE COMPARATOR

Group B received intravenous (IV) dexamethasone 4 mg after intubation \& IV granisetron 1 mg at the end of surgery

Drug: Dexamethasone, granisetron & palonosetron

Group A

EXPERIMENTAL

Group A received 1 ml of intravenous (IV) 0.9% saline after intubation and IV palonosetron 0.075 mg at the end of operation.

Drug: Dexamethasone, granisetron & palonosetron

Interventions

Dexamethasone, granisetron & palonosetron DRUG

. 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

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 18 to 65 years old
• American Society of Anesthesiologists (ASA) physical status I or II
• scheduled for elective laparoscopic cholecystectomy under general anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Kebangsaan Malaysia Medical Centre: lead

Study Sites (1)

Hospital Canselor Tuanku Muhriz Universiti Kebangsaan Malaysia

Cheras, Kuala Lumpur, 56000, Malaysia

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Dexamethasone; Granisetron; Palonosetron

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Quinuclidines; Isoquinolines

Study Officials

• Maryam Budiman, M.D.

  Faculty of Medicine, Universiti Kebangsaan Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: September 21, 2023
• Study Start: May 10, 2018
• Primary Completion: May 10, 2019
• Study Completion: May 10, 2019
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)