Dexmedetomidine for Prophylaxis Against PONV in Highly Susceptible Patients.

Not Applicable

Completed

• Conditions: Postoperative Nausea and Vomiting; Head and Neck Surgeries
• Interventions: Drug: Dexmedetomidine Hydrochloride 0.75 mic/kg bolus; Drug: Placebo; Drug: Dexmedetomidine Hydrochloride 0.5 mic/kg bolus

• Registration Number: NCT05134363
• Lead Sponsor: Cairo University

Brief Summary

The study aims to compare between two bolus doses of dexmedetomidine in preventing PONV in highly susceptible patients.

Detailed Description

Being A challenging complaint, many studies tried to find an effective preventive strategies for PONV. In this study protocol the investigators aim to compare between 0.5 mic/kg and 0.75 mic/kg bolus doses of dexmedetomidine when given toward the end of head and neck surgeries in highly susceptible patients with a controlled group receiving ondansetron.

The primary outcome is the 1st 24 hours incidence of PONV

Other outcomes include:

* Time to 1st call for rescue antiemetic and the total amount of antiemetics

* Number of PONV attacks

* Post operative pain score with visual analogous scale (VAS) and time to 1st call for rescue analgesia

* Sedation Score using Observer's Assessment of Alertness and sedation (OAA/S)

* Patient satisfaction

* Vital signs in the 1st 24 hours

Study Timeline

• Study Start: 2021-08-11
• Study First Submitted: 2021-10-30
• Study First Submitted QC: 2021-11-23
• Study First Posted: 2021-11-24
• Primary Completion: 2023-06-20
• Study Completion: 2023-06-20
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-28
• Last Update Posted: 2023-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• Two risk factors or more for PONV ( female, non-smoking, postoperative opioids, history of motion sickness or PONV )
• Head and neck surgeries in adults
• ASA ( I , II )

Exclusion Criteria

• Patients on ( steroids , antiemetics or any drug caude emesis )
• Any active cardiac condition at the time of the surgery
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dexmedetomidine 0.75 mic/kg bllus	Dexmedetomidine Hydrochloride 0.75 mic/kg bolus	selective alpha 2 adrenergic receptor agonist
Placebo group	Placebo	receving equal volume of normal saline
Dexmedetomidine 0.5 mic/kg bolus	Dexmedetomidine Hydrochloride 0.5 mic/kg bolus	selective alpha 2 adrenergic receptor agonist

Primary Outcome Measures

Name	Time	Method
Incidence of PONV in the 1st 24 hours postoperatively	The first 24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours )	The overall incidence of nausea and vomiting in the 1st 24 hours following Head and neck surgeries.

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction	The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours )	The patient completes a simple questionnaire with 0= very satisfied 1 = satisfied 2= not satisfied
Number of PONV attacks	The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours )	Number of PONV attacks in the 1st 24 hours following Head and neck surgeries
Pain score postoperatively.	The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours )	Pain assessement using visual analogous scale score (0-10) with 10 denoting the worst pain expressed and zero= no pain
Sedation score	The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours )	using Observer's assessment of ALERTNESS and Sedation (1-5)with 1 = unconscious and 5= Alert
Blood pressure	The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours )	Mean arterial blood pressure (MAP) in the 1st 24 hours
The time to 1st call for rescue antiemetic	In the 1st 24 hours	time to 1st call for rescue antiemetic and the severity of nausea ( using the 11 verbal 11-point rating scale 0= no nausea 10= the worst nausea
Heart Rate (HR)	The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours )	Pulse rate in the 1st 24 hours
Total amount of morphine consumption	The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours )	morphine consumed in thw 1st 24 hours in milligrams.
The time to 1st call for rescue analgesia	In the first 24 hours	time to 1st call for rescure analgesic medication in the 1st 24 hours postoperatively
The severity of nausea.	The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours )	the severity of nausea ( using the 11 verbal 11-point rating scale 0= no nausea 10= the worst nausea

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt