Effects of Single dose Dexmedetomidine on recovery profile in ambulatory surgery

Effect of single-dose dexmedetomidine on postoperative recovery after ambulatory ureteroscopy and ureteric stenting: a double blind randomized controlled study

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12617001120369

Enrollment

Registered

2017-07-31

Start date

2008-10-21

Completion date

2010-04-27

Last updated

2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 .

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

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.

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.

Outcome results