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

ISRCTN ISRCTN56992547
DOI https://doi.org/10.1186/ISRCTN56992547
Secondary identifying numbers N/A
Submission date
10/04/2017
Registration date
12/04/2017
Last edited
07/06/2023
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Obstructive sleep apnoea (OSA) is a common condition in which the upper airways (wind pipe) collapse repeatedly during sleep, stopping the flow of air into the lungs. This prevents the sufferer from being able to breathe properly while they are asleep, causing excessive sleepiness throughout their waking hours. Patients with OSA are at risk of developing lung complications following surgery, meaning that use of pain killers and sedatives during care after surgery needs to be restricted. Dexmedetomidine is an anxiety reducing, sedative, and pain medication, which may be useful in the post-operative period for patients with OSA who are having surgery. Ketofol is a medication made from a mixture of ketamine (a medication mainly used for starting and maintaining anesthesia) and propofol (a sedative), which has been shown to be effective at reducing the dose of sedatives needed by patients and so reducing the risk of lung complications. The aim of this study is to look at the effectiveness of dexmedetomine versus ketofol for sedation of patients with OSA after surgery that need help breathing.

Who can participate?
Adults aged between 18 and 50 years who have obstructive sleep apnea and require mechanical ventilation.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive dexmedetomine through a drip and those in the second group receive ketofol through a drip to provide sedation. Both groups receive sedation for a total of 12 hours after surgery while they undergo mechanical ventilation (use of a breathing machine). The length of time they need to stay on the breathing machine and the length of their hospital stay is recorded. In addition, their vital signs are monitored throughout.

What are the possible benefits and risks of participating?
There are no notable benefits or risks involved with participating.

Where is the study run from?
Benisuef University Hospital (Egypt)

When is the study starting and how long is it expected to run for?
May 2016 to April 2017

Who is funding the study?
Investigator initiated and funded (Egypt)

Who is the main contact?
Dr Hatem Elmoutaz
form@med.bsu.edu.eg

Contact information

Dr Hatem Elmoutaz
Scientific

Beni Suef University
Faculty of Medicine
Qism Bani Sweif
Beni Suef
11391
Egypt

Phone +20 100 171 6514
Email form@med.bsu.edu.eg

Study information

Study designRandomised parallel trial
Primary study designInterventional
Secondary study designRandomised parallel trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleEfficacy of Dexmedetomine versus Ketofol for sedation of postoperative mechanically ventilated patients with obstructive sleep apnea
Study objectivesThe aim of this study is to compare the efficacy of Dexmedetomine versus Ketofol for sedation of postoperative mechanically ventilated patients with obstructive sleep apnea.
Ethics approval(s)Faculty of Medicine- Beni Suef University Research Ethical Committee, 19/03/2017, ref: FWA00015574
Health condition(s) or problem(s) studiedObstructive sleep apnea
InterventionPatients 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.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Dexmedetomine, ketamine, propofol
Primary outcome measure1. 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 measures1. 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
Overall study start date01/05/2016
Completion date01/04/2017

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit50 Years
SexBoth
Target number of participants24 patients
Total final enrolment24
Key inclusion criteria1. Aged 18-50 years
2. Obstructive sleep apnea
3. Require mechanical ventilation postoperatively
Key exclusion criteria1. 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
Date of first enrolment10/05/2016
Date of final enrolment10/03/2017

Locations

Countries of recruitment

  • Egypt

Study participating centre

Benisuef University Hospital
Mohamed Hassan Street
Beni Suef
62511
Egypt

Sponsor information

Beni Suef University
Hospital/treatment centre

Faculty of Medicine
Qism Bani Sweif
Beni Suef
11391
Egypt

ROR logo "ROR" https://ror.org/05pn4yv70

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date01/04/2018
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a high-impact peer reviewed journal.
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 28/01/2018 07/06/2023 Yes No

Editorial Notes

07/06/2023: Publication reference and total final enrolment added.