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
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
Scientific
Beni Suef University
Faculty of Medicine
Qism Bani Sweif
Beni Suef
11391
Egypt
| Phone | +20 100 171 6514 |
|---|---|
| form@med.bsu.edu.eg |
Study information
| Study design | Randomised parallel trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Efficacy of Dexmedetomine versus Ketofol for sedation of postoperative mechanically ventilated patients with obstructive sleep apnea |
| Study objectives | 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(s) | Faculty of Medicine- Beni Suef University Research Ethical Committee, 19/03/2017, ref: FWA00015574 |
| Health condition(s) or problem(s) studied | Obstructive sleep apnea |
| Intervention | 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. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Dexmedetomine, ketamine, propofol |
| Primary outcome measure | 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 study start date | 01/05/2016 |
| Completion date | 01/04/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 50 Years |
| Sex | Both |
| Target number of participants | 24 patients |
| Total final enrolment | 24 |
| Key inclusion criteria | 1. Aged 18-50 years 2. Obstructive sleep apnea 3. Require mechanical ventilation postoperatively |
| Key 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 |
| Date of first enrolment | 10/05/2016 |
| Date of final enrolment | 10/03/2017 |
Locations
Countries of recruitment
- Egypt
Study participating centre
Beni Suef
62511
Egypt
Sponsor information
Hospital/treatment centre
Faculty of Medicine
Qism Bani Sweif
Beni Suef
11391
Egypt
"ROR" |
https://ror.org/05pn4yv70 |
|---|
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/04/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned 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.
