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Dexmedetomidine for Prophylaxis Against PONV in Highly Susceptible Patients.

Primary Purpose

Postoperative Nausea and Vomiting, Head and Neck Surgeries

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Dexmedetomidine Hydrochloride 0.5 mic/kg bolus

Dexmedetomidine Hydrochloride 0.75 mic/kg bolus

Placebo

About this trial

This is an interventional prevention trial for Postoperative Nausea and Vomiting focused on measuring Dexmedetomidine, PONV, ondansetron, post operative, nausea, vomiting

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Cairo University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Dexmedetomidine 0.5 mic/kg bolus

dexmedetomidine 0.75 mic/kg bllus

Placebo group

Arm Description

selective alpha 2 adrenergic receptor agonist

receving equal volume of normal saline

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of PONV attacks

Number of PONV attacks in the 1st 24 hours following Head and neck surgeries

Pain score postoperatively.

Pain assessement using visual analogous scale score (0-10) with 10 denoting the worst pain expressed and zero= no pain

Sedation score

using Observer's assessment of ALERTNESS and Sedation (1-5)with 1 = unconscious and 5= Alert

Patient satisfaction

The patient completes a simple questionnaire with 0= very satisfied 1 = satisfied 2= not satisfied

Blood pressure

Mean arterial blood pressure (MAP) in the 1st 24 hours

Heart Rate (HR)

Pulse rate in the 1st 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

The severity of nausea.

the severity of nausea ( using the 11 verbal 11-point rating scale 0= no nausea 10= the worst nausea

Total amount of morphine consumption

morphine consumed in thw 1st 24 hours in milligrams.

The time to 1st call for rescue analgesia

time to 1st call for rescure analgesic medication in the 1st 24 hours postoperatively

Full Information

NCT ID

NCT05134363

First Posted

October 30, 2021

Last Updated

August 28, 2023

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT05134363

Brief Title

Dexmedetomidine for Prophylaxis Against PONV in Highly Susceptible Patients.

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

August 11, 2021 (Actual)

Primary Completion Date

June 20, 2023 (Actual)

Study Completion Date

June 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Nausea and Vomiting, Head and Neck Surgeries

Keywords

Dexmedetomidine, PONV, ondansetron, post operative, nausea, vomiting

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

comparative study between two doses and a 3rd control group

Masking

Investigator

Allocation

Randomized

Enrollment

180 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dexmedetomidine 0.5 mic/kg bolus

Arm Type

Active Comparator

Arm Description

selective alpha 2 adrenergic receptor agonist

Arm Title

dexmedetomidine 0.75 mic/kg bllus

Arm Type

Active Comparator

Arm Description

selective alpha 2 adrenergic receptor agonist

Arm Title

Placebo group

Arm Type

Placebo Comparator

Arm Description

receving equal volume of normal saline

Intervention Type

Drug

Intervention Name(s)

Dexmedetomidine Hydrochloride 0.5 mic/kg bolus

Intervention Description

comparison between two bolus doses of dexmedetomidine with a placebo group

Intervention Type

Drug

Intervention Name(s)

Dexmedetomidine Hydrochloride 0.75 mic/kg bolus

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

equal volume of normal saline

Primary Outcome Measure Information:

Title

Incidence of PONV in the 1st 24 hours postoperatively

Description

The overall incidence of nausea and vomiting in the 1st 24 hours following Head and neck surgeries.

Time Frame

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 Measure Information:

Title

Number of PONV attacks

Description

Number of PONV attacks in the 1st 24 hours following Head and neck surgeries

Time Frame

The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours )

Title

Pain score postoperatively.

Description

Pain assessement using visual analogous scale score (0-10) with 10 denoting the worst pain expressed and zero= no pain

Time Frame

The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours )

Title

Sedation score

Description

using Observer's assessment of ALERTNESS and Sedation (1-5)with 1 = unconscious and 5= Alert

Time Frame

The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours )

Title

Patient satisfaction

Description

The patient completes a simple questionnaire with 0= very satisfied 1 = satisfied 2= not satisfied

Time Frame

The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours )

Title

Blood pressure

Description

Mean arterial blood pressure (MAP) in the 1st 24 hours

Time Frame

The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours )

Title

Heart Rate (HR)

Description

Pulse rate in the 1st 24 hours

Time Frame

The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours )

Title

The time to 1st call for rescue antiemetic

Description

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

Time Frame

In the 1st 24 hours

Title

The severity of nausea.

Description

the severity of nausea ( using the 11 verbal 11-point rating scale 0= no nausea 10= the worst nausea

Time Frame

The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours )

Title

Total amount of morphine consumption

Description

morphine consumed in thw 1st 24 hours in milligrams.

Time Frame

The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours )

Title

The time to 1st call for rescue analgesia

Description

time to 1st call for rescure analgesic medication in the 1st 24 hours postoperatively

Time Frame

In the first 24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Cairo University

City

Cairo

ZIP/Postal Code

11511

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

10485781

Citation

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.

Results Reference

background

PubMed Identifier

23698545

Citation

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.

Results Reference

result

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Dexmedetomidine for Prophylaxis Against PONV in Highly Susceptible Patients.

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