Skip to main content
OpenTrials
Completed

NCT Number: NCT05134363

Dexmedetomidine for Prophylaxis Against PONV in Highly Susceptible Patients.

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Postoperative Nausea and Vomiting Head and Neck Surgeries Nausea Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, 11511, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine Hydrochloride 0.5 mic/kg bolus

Drug

comparison between two bolus doses of dexmedetomidine with a placebo group

Dexmedetomidine Hydrochloride 0.75 mic/kg bolus

Drug

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

Placebo

Drug

equal volume of normal saline

Primary outcomes

  1. Incidence of PONV in the 1st 24 hours postoperatively

    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 )

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

Secondary outcomes

  1. Number of PONV attacks

    Time frame: 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

  2. Pain score postoperatively.

    Time frame: 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

  3. Sedation score

    Time frame: 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

  4. Patient satisfaction

    Time frame: 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

  5. Blood pressure

    Time frame: 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

  6. Heart Rate (HR)

    Time frame: 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

  7. The time to 1st call for rescue antiemetic

    Time frame: 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

  8. The severity of 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 )

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

  9. Total amount of morphine consumption

    Time frame: 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.

  10. The time to 1st call for rescue analgesia

    Time frame: In the first 24 hours

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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 24, 2021
Registry last updated
Aug 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.