Clinical trial NCT05134363: Dexmedetomidine for Prophylaxis Against PONV in Highly Susceptible Patients.
Official title: Dexmedetomidine for Prophylaxis Against Postoperative Nausea and Vomiting in Highly Susceptible Patients: a Randomised Controlled Comparison of Two Bolus Doses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Nausea and Vomiting
Head and Neck Surgeries
Keywords: Dexmedetomidine
PONV
ondansetron
post operative
nausea
vomiting
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-11-24
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: comparative study between two doses and a 3rd control group
Primary purpose: PREVENTION

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

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

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

Primary outcomes:
measure: Incidence of PONV in the 1st 24 hours postoperatively
timeFrame: 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:
measure: Number of PONV attacks
timeFrame: The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours )
measure: Pain score postoperatively.
timeFrame: The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours )
measure: Sedation score
timeFrame: The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours )
measure: Patient satisfaction
timeFrame: The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours )
measure: Blood pressure
timeFrame: The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours )
measure: Heart Rate (HR)
timeFrame: The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours )
measure: The time to 1st call for rescue antiemetic
timeFrame: In the 1st 24 hours
measure: The severity of nausea.
timeFrame: The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours )
measure: Total amount of morphine consumption
timeFrame: The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours )
measure: The time to 1st call for rescue analgesia
timeFrame: In the first 24 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References:
citation: 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.
citation: 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.