Prophylaxis Against Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy

NCT06017167 | Unknown Phase 2

• 1 other identifier: PONV after lap cholecystectomy
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to compare antiemetic effects between dexmedetomidine and ondansteron in the first group versus dexamethasone and ondansteron in the second group. The primary outcome in this study is incidence of postoperative nausea and vomiting after laparoscopic cholecystectomy. The secondary outcomes are:

• The severity of post operative nausea and vomiting.
• Use of rescue antiemetic drugs.
• Postoperative pain and sedation.

Conditions

Postoperative Nausea and Vomiting; Laparoscopic Cholecystectomy

Keywords

dexamethasone; dexmedetomidine; ondansetron

Outcome Measures

Primary Outcomes (1)

• The incidence of postoperative nausea and vomiting after laparoscopic cholecystectomy.

  The incidence of vomiting, use of rescue antiemetics, and analgesic requirements were recorded at 0 to 1 hours after surgery in the postanesthetic care unit (PACU)At 6 and 24 hours after surgery, the incidence and severity of PONV were assessed using the Rhodes Index of nausea, vomiting, and retching.

  through out 24 hours after surgery.

Secondary Outcomes (3)

• The severity of post operative nausea and vomiting.

  During 24 hours after surgery.

• - Postoperative pain

  During 24 hours after surgery.

• - Postoperative sedation

  During 24 hours after surgery.

Study Arms (2)

Dexmedetomidine Group

ACTIVE COMPARATOR

will receive ondansetron 4mg + dexmedetomidine 0.5 ug/kg + normal saline to complete 10 ml. volume IV infusion over 10 minutes.

Drug: Ondansetron 4mg + dexmedetomidine 0.5 ug/kg + normal saline .

Dexamethasone Group

ACTIVE COMPARATOR

will receive Ondansetron 4mg + dexamethasone 8mg + normal saline to complete 10 ml. volume IV infusion over 10 minutes.

Drug: Ondansetron 4mg + dexamethasone 8mg + normal saline.

Interventions

Ondansetron 4mg + dexmedetomidine 0.5 ug/kg + normal saline . DRUG

compare antiemetic effects between dexmedetomidine and ondansetron in the first group versus dexamethasone and ondansetron in the second group

Also known as: ondansetron 4mg (Zofran; GlaxoSmithKline, Alexandria, USA, dexmedetomidine (Precedex; Ho-Spira Inc., Lake Forest, Illinois, USA

Dexmedetomidine Group

Ondansetron 4mg + dexamethasone 8mg + normal saline. DRUG

Group II: Ondansetron 4mg + dexamethasone 8mg + normal saline.

Also known as: ondansetron 4mg (Zofran; GlaxoSmithKline, Alexandria, USA, dexamethasone; Amriya Pharmaceutical Industries, Egypt

Dexamethasone Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: According to APFEL score female is a risk factor for PONV.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients aged between 18 and 65 years
• ASA I or II
• patients scheduled for elective laparoscopic cholecystectomy surgery will be included in this study.

You may not qualify if:

• Females above 65 years old.
• patients under 18 years old.
• ASA \> II.
• Obesity (BMI\>40 kgm2).
• Known hypersensitivity to drugs used in the study protocol.
• Comorbidities that were known to increase the risk of PONV (e.g. vestibular disease).
• Liver or renal dysfunction (liver enzyme or creatinine 1.5 times higher than normal).
• Alcoholism or drug abuse.
• Use of antiemetics and psychotropic drugs or glucocorticoids within 24 h before surgery.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University hospitals

Tanta, Algharbia, 31511, Egypt

RECRUITING

Related Publications (1)

• Rhodes VA, McDaniel RW. The Index of Nausea, Vomiting, and Retching: a new format of the lndex of Nausea and Vomiting. Oncol Nurs Forum. 1999 Jun;26(5):889-94.

  PMID: 10382187 BACKGROUND

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Ondansetron; Dexmedetomidine; Saline Solution; halofantrine; Dexamethasone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Mohamed A. Lotfy, PHD

  Assistant Professor of Anesthesia and Intensive Care, Tanta Univ

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yasmine M. Eldeba, BA

CONTACT

0021097732321; yasmine162078_pg@med.tanta.edu.eg

Rehab S. Elkalla, PHD

CONTACT

01285700765; rehab.mohamed@med.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double (Participant, Outcomes Assessor) * The participants will be kept blind in both groups. * Outcome assessors will be blinded as they will be anesthesia resident and nurse not participating in the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor of Anaesthesia and ICU Department

Model Details: Patients will be randomly classified with computer generated random numbers into two equal groups (each group 35 patients) Group I: will receive Ondansetron 4mg + dexmedetomidine 0.5 ug/kg + normal saline to complete 10 ml. volume IV infusion over 10 minutes. Group II: will receive Ondansetron 4mg + dexamethasone 8mg + normal saline to complete 10 ml volume IV ifusion over 10 minutes.

Study Record Dates

• First Submitted: August 14, 2023
• First Posted: August 30, 2023
• Study Start: September 15, 2022
• Primary Completion: September 1, 2023
• Study Completion: October 1, 2023
• Last Updated: August 30, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: within 6 months after publishing the study
• Access Criteria: yasmine162078\ pg@med.tanta.edu.eg

Locations

EG (1)