Dexmedetomidine for Prophylaxis Against PONV in Highly Susceptible Patients.

Sponsor

Cairo University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05134363

Collaborator

(none)

180

Enrollment

Location

Arms

11.7

Anticipated Duration (Months)

15.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Postoperative Nausea and Vomiting Head and Neck Surgeries	Drug: Dexmedetomidine Hydrochloride 0.5 mic/kg bolus Drug: Dexmedetomidine Hydrochloride 0.75 mic/kg bolus Drug: Placebo	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

180 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

comparative study between two doses and a 3rd control groupcomparative study between two doses and a 3rd control group

Masking:

Single (Investigator)

Primary Purpose:

Prevention

Official Title:

Dexmedetomidine for Prophylaxis Against Postoperative Nausea and Vomiting in Highly Susceptible Patients: a Randomised Controlled Comparison of Two Bolus Doses

Actual Study Start Date :

Aug 11, 2021

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Aug 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Dexmedetomidine 0.5 mic/kg bolus selective alpha 2 adrenergic receptor agonist	Drug: Dexmedetomidine Hydrochloride 0.5 mic/kg bolus comparison between two bolus doses of dexmedetomidine with a placebo group
Active Comparator: dexmedetomidine 0.75 mic/kg bllus selective alpha 2 adrenergic receptor agonist	Drug: Dexmedetomidine Hydrochloride 0.75 mic/kg bolus comparison between two bolus doses of dexmedetomidine with a conventional group receiving ondansetron.
Placebo Comparator: Placebo group receving equal volume of normal saline	Drug: Placebo equal volume of normal saline

Arm

Intervention/Treatment

Active Comparator: Dexmedetomidine 0.5 mic/kg bolus

selective alpha 2 adrenergic receptor agonist

Drug: Dexmedetomidine Hydrochloride 0.5 mic/kg bolus

comparison between two bolus doses of dexmedetomidine with a placebo group

Active Comparator: dexmedetomidine 0.75 mic/kg bllus

selective alpha 2 adrenergic receptor agonist

Drug: Dexmedetomidine Hydrochloride 0.75 mic/kg bolus

comparison between two bolus doses of dexmedetomidine with a conventional group receiving ondansetron.

Placebo Comparator: Placebo group

receving equal volume of normal saline

Drug: Placebo

equal volume of normal saline

Outcome Measures

Primary Outcome Measures

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

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
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
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
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
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
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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 )