Dexmedetomidine for Prophylaxis Against PONV in Highly Susceptible Patients.

Overview

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

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Investigator)
  • Study Primary Completion Date: April 2022

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

Interventions

  • Drug: Dexmedetomidine Hydrochloride 0.5 mic/kg bolus
    • comparison between two bolus doses of dexmedetomidine with a placebo group
  • Drug: Dexmedetomidine Hydrochloride 0.75 mic/kg bolus
    • comparison between two bolus doses of dexmedetomidine with a conventional group receiving ondansetron.
  • Drug: Placebo
    • equal volume of normal saline

Arms, Groups and Cohorts

  • Active Comparator: Dexmedetomidine 0.5 mic/kg bolus
    • selective alpha 2 adrenergic receptor agonist
  • Active Comparator: dexmedetomidine 0.75 mic/kg bllus
    • selective alpha 2 adrenergic receptor agonist
  • Placebo Comparator: Placebo group
    • receving equal volume of normal saline

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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.
  • 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

Participating in This Clinical Trial

Inclusion Criteria

  • More than 2 risk factors 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Cairo University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Amr Raafat Mahmoud Seif, Principal Investigator – Cairo University

References

Apfel CC, Läärä 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.

Citations Reporting on Results

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.

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