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Trial registered on ANZCTR


Registration number
ACTRN12617001120369
Ethics application status
Approved
Date submitted
1/06/2017
Date registered
31/07/2017
Date last updated
31/07/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of Single dose Dexmedetomidine on recovery profile in ambulatory surgery
Scientific title
Effect of single-dose dexmedetomidine on postoperative recovery after ambulatory ureteroscopy and ureteric stenting: a double blind randomized controlled study
Secondary ID [1] 292073 0
Nil
Universal Trial Number (UTN)
U1111-1197-3249
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
post operative pain
303487 0
Condition category
Condition code
Anaesthesiology 302903 302903 0 0
Anaesthetics
Anaesthesiology 302904 302904 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sixty patients were randomised to receive IV dexmedetomidine 0.5 mcg.kg-1 (Group DEX, n=30) or IV 0.9% saline (Group P, n=30) as intravenous infusion over 20 minutes at pre induction of anaesthesia .
Intervention code [1] 298213 0
Treatment: Drugs
Comparator / control treatment
The control group received intra venous saline 20 mls.
Control group
Placebo

Outcomes
Primary outcome [1] 302291 0
To assess the effect of Dexmedetomidine on the patient's minimum alveolar concentration (MAC). The MAC of the patient is monitored using a tool already incorporated in the general anaesthesia machine.
Timepoint [1] 302291 0
every 5 minutes intraoperatively
Secondary outcome [1] 335394 0
To assess postoperative pain scores using a pain assessment scale ie the visual analogue score which is widely used in many hospital around the world.
Timepoint [1] 335394 0
From immediately post operation and every 12 hours for 3 days post operative.

Eligibility
Key inclusion criteria
All patients of American Society Anaesthesiologists physical status I-II, aged between 18-65 years who underwent elective ureteroscopy and ureteric stenting in our ambulatory day care centre.
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
All patients with increased serum creatinine (> 200µmolL-1), advanced liver disease (liver enzymes twice the normal range or higher), those with a history of chronic use of sedatives/ narcotics or analgesics, known alcohol or drug abuse, allergy to study medication and those devoid of postoperative telephone access.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes that concealed group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
using a computer generated random number table in blocks of ten.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The sample size was based on our primary outcome measure of anaesthetic minimum alveolar concentration (MAC). From an initial pilot study involving 16 patients, we found the mean (SD) MAC of Sevoflurane to be 0.85 (0.19). We deemed a MAC reduction of 0.25 to be a clinically significant difference between the two groups. Prospective power analysis indicated that with a = 0.05 and power of 80%, 25 patients per group were needed. Therefore we recruited 30 patients per group to account for dropouts. Parametric data and non-parametric data was analysed with Student’s t test and Mann-Whitney U-test respectively, and Fisher’s exact test was used to compare side effects using SPSS 15.0 TM (SPSS Inc., Chicago, IL, USA) software. A p value of < 0.05 was deemed statistically significant.

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] 8931 0
Malaysia
State/province [1] 8931 0
Kuala Lumpur

Funding & Sponsors
Funding source category [1] 296599 0
University
Name [1] 296599 0
university Malaya
Address [1] 296599 0
Dept of Anaesthesiology,
Faculty of Medicine,
Jalan Lembah Pantai,
50603 Kulala Lumpur,
Malaysia
Country [1] 296599 0
Malaysia
Primary sponsor type
University
Name
University Malaya
Address
Dept of Anaesthesiology,
Faculty of Medicine,
Jalan Lembah Pantai,
50603 Kulala Lumpur,
Malaysia
Country
Malaysia
Secondary sponsor category [1] 295563 0
None
Name [1] 295563 0
Address [1] 295563 0
Country [1] 295563 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297826 0
Universiti Malaya Medical centre Ethics committee
Ethics committee address [1] 297826 0
Jln Lembah Pantai,
50603 Kuala Lumpur
Ethics committee country [1] 297826 0
Malaysia
Date submitted for ethics approval [1] 297826 0
30/07/2008
Approval date [1] 297826 0
27/08/2008
Ethics approval number [1] 297826 0
672.7

Summary
Brief summary
We evaluated the effect of a single pre-induction dose of dexmedetomidine on anaesthetic requirements, postoperative pain and clinical recovery after ambulatory ureteroscopy and ureteric stenting under general anaesthesia. Sixty patients were randomised to receive IV dexmedetomidine 0.5 mcg.kg-1 (Group DEX, n=30) or IV saline (Group P, n=30) maintained with Sevoflurane: oxygen: air, titrated to BIS 40-60. Pain intensity, sedation, rescue analgesics, nausea/vomiting and resumption of daily activities were recorded at 1 hour, and postoperative day (POD) 1-5. Group DEX patients had significant reduction in sevoflurane minimum alveolar concentration (MAC), mean (SD) DEX vs. Placebo 0.6 (0.2) vs. 0.9 (0.1), p = 0.037; reduced postoperative resting pain at 1hr (VAS 0-10) (mean (SD) 1.00 (1.84) vs. 2.63 (2.78), p = 0.004), POD 1 (mean (SD) 1.50 (1.48) vs. 2.87 (2.72), p = 0.002), POD 2 (0.53 (0.97) vs. 1.73 (1.96), p = 0.001) and POD 3 (0.30 (0.75) vs. 0.89 (1.49), p = 0.001). DEX patients also had less pain on movement POD 1 (3.00 (2.12) vs. 4.30 (3.10), p = 0.043) and POD 2 (2.10 (1.98) vs. 3.10 (2.46), p = 0.040), with higher resumption of daily activities by 48 hours compared to placebo, 87% vs. 63%, p = 0.04. We conclude that a single dose of dexmedetomidine was a useful adjuvant in reducing MAC and postoperative pain (at 1hr and POD 1-3), facilitating faster return to daily activities by 48hr.
Trial website
Trial related presentations / publications
none
Public notes

Contacts
Principal investigator
Name 75202 0
A/Prof Ina Ismiarti Shariffuddin
Address 75202 0
Dept of Anaesthesiology,
Faculty of Medicine,
Jln Lembah Pantai,
50603 Kuala Lumpur,
Malaysia
Country 75202 0
Malaysia
Phone 75202 0
+60379492052
Fax 75202 0
+60379556705
Email 75202 0
inashariffuddin@gmail.com
Contact person for public queries
Name 75203 0
Dr Ina Ismiarti Shariffuddin
Address 75203 0
Dept of Anaesthesiology,
Faculty of Medicine,
Jln Lembah Pantai,
50603 Kuala Lumpur,
Malaysia
Country 75203 0
Malaysia
Phone 75203 0
+60379492052
Fax 75203 0
+60379556705
Email 75203 0
inashariffuddin@gmail.com
Contact person for scientific queries
Name 75204 0
A/Prof Ina Ismiarti Shariffuddin
Address 75204 0
Dept of Anaesthesiology,
Faculty of Medicine,
Jln Lembah Pantai,
50603 Kuala Lumpur,
Malaysia
Country 75204 0
Malaysia
Phone 75204 0
+60379492052
Fax 75204 0
+60379556705
Email 75204 0
inashariffuddin@gmail.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