Condition category
Respiratory
Date applied
10/04/2017
Date assigned
12/04/2017
Last edited
12/04/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Hatem Elmoutaz

ORCID ID

Contact details

Beni Suef University
Faculty of Medicine
Qism Bani Sweif
Beni Suef
11391
Egypt
+20 100 171 6514
form@med.bsu.edu.eg

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

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

Acronym

Study hypothesis

The 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

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

Study design

Randomised parallel trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Obstructive sleep apnea

Intervention

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

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 type

Drug

Phase

Not Applicable

Drug names

Primary outcome measures

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 measures

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

Overall trial start date

01/05/2016

Overall trial end date

01/04/2017

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

24 patients

Participant 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

Recruitment start date

10/05/2016

Recruitment end date

10/03/2017

Locations

Countries of recruitment

Egypt

Trial participating centre

Benisuef University Hospital
Mohamed Hassan Street
Beni Suef
62511
Egypt

Sponsor information

Organisation

Beni Suef University

Sponsor details

Faculty of Medicine
Qism Bani Sweif
Beni Suef
11391
Egypt

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

Intention to publish date

01/04/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes