Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Dexmedetomidine for Prophylaxis Against PONV in Highly Susceptible Patients.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05134363
Recruitment Status : Active, not recruiting
First Posted : November 24, 2021
Last Update Posted : November 24, 2021
Sponsor:
Information provided by (Responsible Party):
Amr Raafat Mahmoud Seif, Cairo University

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

Condition or disease Intervention/treatment Phase
Postoperative Nausea and Vomiting Head and Neck Surgeries Drug: Dexmedetomidine Hydrochloride 0.5 mic/kg bolus Drug: Dexmedetomidine Hydrochloride 0.75 mic/kg bolus Drug: Placebo Not Applicable

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: comparative study between two doses and a 3rd control group
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Dexmedetomidine for Prophylaxis Against Postoperative Nausea and Vomiting in Highly Susceptible Patients: a Randomised Controlled Comparison of Two Bolus Doses
Actual Study Start Date : August 11, 2021
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05134363


Locations
Layout table for location information
Egypt
Cairo University
Cairo, Egypt, 11511
Sponsors and Collaborators
Cairo University
Publications of Results:
Other Publications:
Layout table for additonal information
Responsible Party: Amr Raafat Mahmoud Seif, Principal Investigator, Cairo University
ClinicalTrials.gov Identifier: NCT05134363    
Other Study ID Numbers: MD-208-2021
First Posted: November 24, 2021    Key Record Dates
Last Update Posted: November 24, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Keywords provided by Amr Raafat Mahmoud Seif, Cairo University:
Dexmedetomidine
PONV
ondansetron
post operative
nausea
vomiting
Additional relevant MeSH terms:
Layout table for MeSH terms
Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Postoperative Complications
Pathologic Processes
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action