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Trial registered on ANZCTR


Registration number
ACTRN12609000731291
Ethics application status
Approved
Date submitted
21/08/2009
Date registered
25/08/2009
Date last updated
9/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
the use of dexmedetomidine as an analgesic after uvulopalatopharyngoplasty for obstructive sleep apnea.
Scientific title
analgesic and sedative properties of dexmedetomidine infusion after uvulopalatopharyngoplasty for obstructive sleep apnea.
Secondary ID [1] 922 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obstructive sleep apnea 237221 0
Condition category
Condition code
Respiratory 237539 237539 0 0
Sleep apnoea
Anaesthesiology 239869 239869 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
dexmedetomidine loading dose:1 microgram /kg.intravenous infusion over 20min;this was administered 30 min before the suspected end of surgery
infusion dose:0.6 microgram /kg / h.following the loading infusion and continued till the end of the first postoperative day
Intervention code [1] 236917 0
Treatment: Drugs
Comparator / control treatment
placebo: normal saline infusion; as a loading dose; 30 min before the suspected end of surgery, followed by continous intravenous infusion, with the same infusion 's rate as the testing drug.
Control group
Placebo

Outcomes
Primary outcome [1] 238348 0
postoperative visual analogue pain score
Timepoint [1] 238348 0
Pain scores were recorded using a VAS scale every 30 min during the first 2 h, every 60 min during the next 10 h and every 4 h during the next 36 hours postoperatively
Primary outcome [2] 238349 0
postoperative morphine consumption by patient-controlled analgesia
Timepoint [2] 238349 0
at 12,24,36,48h postoperative.
Secondary outcome [1] 244776 0
postoperative morphine side effects.Most common morphine side effects are nausea and vomiting.The presence of nausea and vomiting was noted(by clinical observation of the patients) using a four-point scale (0=no nausea or vomiting, 1=mild nausea, 2=sever nausea, 3=retching or vomiting).
Timepoint [1] 244776 0
24h postoperative.
Secondary outcome [2] 244777 0
postoperative satisfaction score
Timepoint [2] 244777 0
24h postoperative.

Eligibility
Key inclusion criteria
-frequent loud snoring and arousal from sleep.
-apnea-hypopnea index 20-40.
Minimum age
38 Years
Maximum age
55 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-history of ischemic heart disease.
-long term use of certain medications(beta blockers, sedative and analgesics).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
randomization was carried out by computer generated codes.The codes were maintained in sequentially numbered, opaque envelopes, which were opened before induction of anesthesia.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
randomization was carried out by computer generated codes. The codes were maintained in sequentially numbered, opaque envelopes, which were opened before induction of anesthesia.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 1879 0
Saudi Arabia
State/province [1] 1879 0
eastern

Funding & Sponsors
Funding source category [1] 237315 0
Hospital
Name [1] 237315 0
King Abdullaziz Naval Base Hospital
Address [1] 237315 0
king abdullaziz naval base, jubail 31951.
P.O.Box413
Country [1] 237315 0
Saudi Arabia
Primary sponsor type
Individual
Name
Dr.walid Abd El Mageed
Address
king abdullaziz naval base, jubail 31951.
P.O.Box 413
Country
Saudi Arabia
Secondary sponsor category [1] 236801 0
Individual
Name [1] 236801 0
Dr.Ahmad Nassar
Address [1] 236801 0
king abdullaziz naval base, jubail 31951.
P.O.Box413
Country [1] 236801 0
Saudi Arabia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239411 0
Hospital Ethics Committee
Ethics committee address [1] 239411 0
king abdullaziz naval base hospital , jubail 31951.
P.O.Box413
Ethics committee country [1] 239411 0
Saudi Arabia
Date submitted for ethics approval [1] 239411 0
24/04/2007
Approval date [1] 239411 0
25/05/2007
Ethics approval number [1] 239411 0

Summary
Brief summary
Dexmedetomidine is an alpha2- adrenergic agonist with sedative and analgesic properties. This study aimed to investigate if the use of continuous dexmedetomidine infusion with i.v. morphine patient-controlled analgesia (PCA) could improve postoperative analgesia while reducing opioid consumption and opioid-related side effects.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29889 0
Address 29889 0
Country 29889 0
Phone 29889 0
Fax 29889 0
Email 29889 0
Contact person for public queries
Name 13136 0
Dr.Walid Abd El Mageed
Address 13136 0
King Abdullaziz Naval Base Hospital, Jubail 31951.P.O.Box :413
Country 13136 0
Saudi Arabia
Phone 13136 0
+966 557189366
Fax 13136 0
Email 13136 0
walidabdelmageed@yahoo.com
Contact person for scientific queries
Name 4064 0
Dr.Walid Abd El Mageed
Address 4064 0
King Abdullaziz Naval Base Hospital, Jubail 31951.P.O.Box :413
Country 4064 0
Saudi Arabia
Phone 4064 0
+966 557189366
Fax 4064 0
Email 4064 0
walidabdelmageed@yahoo.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary