Dexmedetomidine for Prophylaxis Against PONV in Highly Susceptible Patients.

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

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

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11511
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

General Publications

• Apfel CC, Laara E, Koivuranta M, Greim CA, Roewer N. A simplified risk score for predicting postoperative nausea and vomiting: conclusions from cross-validations between two centers. Anesthesiology. 1999 Sep;91(3):693-700. doi: 10.1097/00000542-199909000-00022.
• Kim SH, Oh YJ, Park BW, Sim J, Choi YS. Effects of single-dose dexmedetomidine on the quality of recovery after modified radical mastectomy: a randomised controlled trial. Minerva Anestesiol. 2013 Nov;79(11):1248-58. Epub 2013 May 23.

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2021
• Primary Completion (Actual): June 20, 2023
• Study Completion (Actual): June 20, 2023

Study Registration Dates

• First Submitted: October 30, 2021
• First Submitted That Met QC Criteria: November 23, 2021
• First Posted (Actual): November 24, 2021

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 28, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: nausea; Dexmedetomidine; vomiting; PONV; ondansetron; post operative
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: MD-208-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No