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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
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
Universal Trial Number (UTN)
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
Anaesthesiology 302904 302904 0 0
Pain management

Study type
Description of intervention(s) / exposure
Sixty patients were randomised to receive IV dexmedetomidine 0.5 (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

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.

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
Both males and females
Can healthy volunteers participate?
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
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
Other design features
Phase 4
Type of endpoint(s)
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 status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment outside Australia
Country [1] 8931 0
State/province [1] 8931 0
Kuala Lumpur

Funding & Sponsors
Funding source category [1] 296599 0
Name [1] 296599 0
university Malaya
Address [1] 296599 0
Dept of Anaesthesiology,
Faculty of Medicine,
Jalan Lembah Pantai,
50603 Kulala Lumpur,
Country [1] 296599 0
Primary sponsor type
University Malaya
Dept of Anaesthesiology,
Faculty of Medicine,
Jalan Lembah Pantai,
50603 Kulala Lumpur,
Secondary sponsor category [1] 295563 0
Name [1] 295563 0
Address [1] 295563 0
Country [1] 295563 0

Ethics approval
Ethics application status
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
Date submitted for ethics approval [1] 297826 0
Approval date [1] 297826 0
Ethics approval number [1] 297826 0

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 (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
Public notes

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,
Country 75202 0
Phone 75202 0
Fax 75202 0
Email 75202 0
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,
Country 75203 0
Phone 75203 0
Fax 75203 0
Email 75203 0
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,
Country 75204 0
Phone 75204 0
Fax 75204 0
Email 75204 0

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