Efficacy of Dexmedetomine versus Ketofol for sedation of postoperative mechanically ventilated patients with obstructive sleep apnea

• Register: ISRCTN
• Last refreshed on: 20 June 2023
• Main ID: ISRCTN56992547
• Date of registration: 12/04/2017
• Prospective Registration: No
• Primary sponsor: Beni Suef University
• Public title: Efficacy of Dexmedetomine versus Ketofol for sedation of postoperative mechanically ventilated patients with obstructive sleep apnea
• Scientific title: Efficacy of Dexmedetomine versus Ketofol for sedation of postoperative mechanically ventilated patients with obstructive sleep apnea
• Date of first enrolment: 10/05/2016
• Target sample size: 24
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN56992547
• Study type: Interventional
• Study design: Randomised parallel trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

Egypt

Contacts

• Name: Hatem Elmoutaz

Key inclusion & exclusion criteria

Inclusion criteria:
1. Aged 18-50 years
2. Obstructive sleep apnea
3. Require mechanical ventilation postoperatively

Exclusion criteria:
1. Prolonged sedation and mechanical ventilation
2. Epileptic patient
3. Patients with known allergy to the studied drugs
4. Pregnancy
5. Severe hepatic, renal or cardiac diseases


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Obstructive sleep apnea
Respiratory
Obstructive sleep apnea

Intervention(s)

Patients are randomised into one of two groups using sealed closed opaque envelopes.

Group 1: Patients receive a loading dose infusion of Dexmedetomine 1 ug/kg over 10 minutes followed by maintenance infusion of 0.5 ug/kg/h.

Group 2: Patients receive ketofol in an initial bolus dose 500 ug/kg of ketamine/propofol 1:1 followed by maintenance dose of 10 ug/kg/min.

Infusion starts for participants in both groups after admission to SICU for short-term sedation of less than 12 hours. All participants are followed up until discharge from the SICU.

Primary Outcome(s)

1. Duration of mechanical ventilation and stay in the SICU is measured in hours
2. Mean time to extubation is measured in minutes
3. Sedation level is assessed using Ramsay sedation scores at baseline, 1 hour after start of the sedation and then every 3 hours until weaning from mechanical ventilation and extubation

Secondary Outcome(s)

1. Heart rate is measured by ECG at baseline, 1 hour after start of the sedation and then every 3 hours until weaning from mechanical ventilation and extubation
2. Invasive mean blood pressure is measured by arterial line at baseline, 1 hour after start of the sedation and then every 3 hours until weaning from mechanical ventilation and extubation
3. Oxygen saturation is measured by pulse oximetry at baseline, 1 hour after start of the sedation and then every 3 hours until weaning from mechanical ventilation and extubation

Secondary ID(s)

N/A

Source(s) of Monetary Support

Investigator initiated and funded

Ethics review

Status:
Approval date:
Contact:

Faculty of Medicine- Beni Suef University Research Ethical Committee, 19/03/2017, ref: FWA00015574

Results

• Results available: Yes
• Date Completed: 01/04/2017