NCT05134363

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

August 11, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2021

Completed
25 days until next milestone

First Posted

Study publicly available on registry

November 24, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2023

Completed
Last Updated

August 30, 2023

Status Verified

August 1, 2023

Enrollment Period

1.9 years

First QC Date

October 30, 2021

Last Update Submit

August 28, 2023

Conditions

Postoperative Nausea and VomitingHead and Neck Surgeries

Keywords

DexmedetomidinePONVondansetronpost operativenauseavomiting

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • 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 )

  • 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 )

  • Sedation score

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

  • Blood pressure

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

  • +5 more secondary outcomes

Study Arms (3)

Dexmedetomidine 0.5 mic/kg bolus

ACTIVE COMPARATOR

selective alpha 2 adrenergic receptor agonist

Drug: Dexmedetomidine Hydrochloride 0.5 mic/kg bolus

dexmedetomidine 0.75 mic/kg bllus

ACTIVE COMPARATOR

selective alpha 2 adrenergic receptor agonist

Drug: Dexmedetomidine Hydrochloride 0.75 mic/kg bolus

Placebo group

PLACEBO COMPARATOR

receving equal volume of normal saline

Drug: Placebo

Interventions

Dexmedetomidine Hydrochloride 0.5 mic/kg bolusDRUG

comparison between two bolus doses of dexmedetomidine with a placebo group

Dexmedetomidine 0.5 mic/kg bolus
Dexmedetomidine Hydrochloride 0.75 mic/kg bolusDRUG

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

dexmedetomidine 0.75 mic/kg bllus
PlaceboDRUG

equal volume of normal saline

Placebo group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 )

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, 11511, Egypt

Location

Related Publications (2)

  • 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.

    PMID: 10485781BACKGROUND

  • 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.

    PMID: 23698545RESULT

MeSH Terms

Conditions

Postoperative Nausea and VomitingNauseaVomiting

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestiveSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: comparative study between two doses and a 3rd control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 30, 2021

First Posted

November 24, 2021

Study Start

August 11, 2021

Primary Completion

June 20, 2023

Study Completion

June 20, 2023

Last Updated

August 30, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)