NCT05988671

Brief Summary

Nausea and vomiting are some of the most common complaints of patients after any anesthesia, which is often associated with postop-erative pain. The double-blind clinical trial study aimed to compare the prophylactic effect of dexamethasone and dexmedetomidine and their combination in reducing postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2023

Shorter than P25 for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 4, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

August 10, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
Last Updated

June 18, 2025

Status Verified

June 1, 2025

Enrollment Period

1.1 years

First QC Date

August 4, 2023

Last Update Submit

June 14, 2025

Conditions

Laparoscopic CholecystectomyPostoperative Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

  • The number of patients suffered from postoperative nausea and vomiting will be recorded in each group.

    24 hours postoperative

Secondary Outcomes (1)

  • antiemetic consumption

    24 hours postoperatively

Study Arms (4)

Control group

PLACEBO COMPARATOR

received 20 ml normal saline

Drug: normal Saline

dexamethasone group

ACTIVE COMPARATOR

received 8mg dexamethasone

Drug: Dexamethasone

dexmedetomidine group

ACTIVE COMPARATOR

received dexmedetomidine 1mic/kg

Drug: Dexmedetomidine

combined group

ACTIVE COMPARATOR

received combination of both 8mg dexamethasone+ dexmedetomidine 1mic/kg

Drug: Combination of dexamethasone + dexmedetomidine

Interventions

normal SalineDRUG

Intraperitoneal route

Control group
DexamethasoneDRUG

Intraperitoneal route

dexamethasone group
DexmedetomidineDRUG

Intraperitoneal route

dexmedetomidine group
Combination of dexamethasone + dexmedetomidineDRUG

Intraperitoneal route

combined group

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients aged from 20 - 50 years
  • ASA I OR II
  • undergo laparoscopic cholecystectomy

You may not qualify if:

  • Patients with history of psychotic illnesses,
  • Parkinson's disease
  • motion disorder
  • Smoker
  • or history of chemotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Haney Baumey

Banhā, 13518, Egypt

Location

Neveen Kohaf

Tanta, 11865, Egypt

Location

Related Publications (1)

  • Bauiomy H, Kohaf NA, Saad M, Rashed ZF, Abosakaya AM. Study the Effect of Intraperitoneal Dexamethasone, Dexmedetomidine, and Their Combination on PONV After Laparoscopic Cholecystectomy: A Randomized Triple-Blind Trial. Anesthesiol Res Pract. 2025 Feb 24;2025:4976637. doi: 10.1155/anrp/4976637. eCollection 2025.

    PMID: 40041104DERIVED

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Saline SolutionDexamethasoneDexmedetomidine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Clinical Pharmacy

Study Record Dates

First Submitted

August 4, 2023

First Posted

August 14, 2023

Study Start

August 10, 2023

Primary Completion

August 30, 2024

Study Completion

August 30, 2024

Last Updated

June 18, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

data could be shared upon reasonable request from principal investigator

Shared Documents
STUDY PROTOCOL, SAP

Locations

EG(2)