Dexmedetomidine for Prophylaxis Against PONV in Highly Susceptible Patients.

Postoperative Nausea and Vomiting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05134363
• Other study ID #: MD-208-2021
• Status: Completed
• Phase: N/A
• Start date: August 11, 2021
• Est. completion date: June 20, 2023

Study information

• Verified date: August 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: June 20, 2023
• Est. primary completion date: June 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

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

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of PONV in the 1st 24 hours postoperatively	The overall incidence of nausea and vomiting in the 1st 24 hours following Head and neck surgeries.	The first 24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours )
Secondary	Number of PONV attacks	Number of PONV attacks in the 1st 24 hours following Head and neck surgeries	The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours )
Secondary	Pain score postoperatively.	Pain assessement using visual analogous scale score (0-10) with 10 denoting the worst pain expressed and zero= no pain	The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours )
Secondary	Sedation score	using Observer's assessment of ALERTNESS and Sedation (1-5)with 1 = unconscious and 5= Alert	The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours )
Secondary	Patient satisfaction	The patient completes a simple questionnaire with 0= very satisfied 1 = satisfied 2= not satisfied	The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours )
Secondary	Blood pressure	Mean arterial blood pressure (MAP) in the 1st 24 hours	The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours )
Secondary	Heart Rate (HR)	Pulse rate in the 1st 24 hours	The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours )
Secondary	The time to 1st call for rescue antiemetic	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	In the 1st 24 hours
Secondary	The severity of nausea.	the severity of nausea ( using the 11 verbal 11-point rating scale 0= no nausea 10= the worst nausea	The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours )
Secondary	Total amount of morphine consumption	morphine consumed in thw 1st 24 hours in milligrams.	The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours )
Secondary	The time to 1st call for rescue analgesia	time to 1st call for rescure analgesic medication in the 1st 24 hours postoperatively	In the first 24 hours