Clinical trial
Dexmedetomidine for Prophylaxis Against Postoperative Nausea and Vomiting in Highly Susceptible Patients: a Randomised Controlled Comparison of Two Bolus Doses
Name
MD-208-2021
Description
The study aims to compare between two bolus doses of dexmedetomidine in preventing PONV in highly susceptible patients.
Trial arms
Trial start
2021-08-11
Estimated PCD
2023-06-20
Trial end
2023-06-20
Status
Completed
Treatment
Dexmedetomidine Hydrochloride 0.5 mic/kg bolus
comparison between two bolus doses of dexmedetomidine with a placebo group
Arms:
Dexmedetomidine 0.5 mic/kg bolus
Dexmedetomidine Hydrochloride 0.75 mic/kg bolus
comparison between two bolus doses of dexmedetomidine with a conventional group receiving ondansetron.
Arms:
dexmedetomidine 0.75 mic/kg bllus
Placebo
equal volume of normal saline
Arms:
Placebo group
Size
180
Primary endpoint
Incidence of PONV in the 1st 24 hours postoperatively
The first 24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours )
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'comparative study between two doses and a 3rd control group', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}}, 'enrollmentInfo': {'count': 180, 'type': 'ACTUAL'}}
Updated at
2023-08-30
1 organization
1 product
1 drug
2 indications
Organization
Cairo UniversityIndication
Postoperative Nausea and VomitingIndication
Head and Neck SurgeryDrug
Varlilumab