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Adequate sedation with single-dose dexmedetomidine in patients undergoing transurethral resection of the prostate with spinal anaesthesia: a dose-response study by age group.

ABSTRACT: Dexmedetomidine (DMT), a highly selective ?2-adrenoceptor agonist, has been used safely as a sedative in patients under regional anesthesia. The purpose of this study was to determine the 50% effective dose (ED50) of single-dose DMT to induce adequate light sedation in elderly patients in comparison with younger patients undergoing transurethral resection of the prostate (TURP) with spinal anesthesia.Forty-two male patients were recruited. The young age group (Group Y) included patients 45 to 64 years old and the old age group (Group O) included patients 65 to 78 years old. After the spinal anesthesia was performed, a pre-calculated dose of DMT was administered for 10 min. The Observer's Assessment of Alertness/Sedation (OAA/S) scale, bispectral index score (BIS) were assessed then at 2-min intervals for 20 min. A modified Dixon's up-and-down method was used to determine the ED50 of the drug for light sedation (OAA/S score 3/4). In the recovery room, regression times of the motor and sensory blocks were recorded.The ED50 of DMT was 0.25 (95% C.I. 0.15-0.35) ?g/kg in Group O and 0.35 (95% C.I. 0.35-0.45) ?g/kg in Group Y (p?=?0.002). The ED95 was 33% lower in Group O compare with Group Y (0.38 (95% C.I. 0.29-0.39) ?g/kg vs. 0.57 (95% C.I. 0.49-0.59) ?g/kg). The regression time of sensory block was longer in Group O than in Group Y (109.0?±?40.2 min vs. 80.0?±?31.6 min) (p?=?0.014).The single-dose of DMT for light sedation was lower by 21% in Group O compare with Group Y underwent TURP with spinal anesthesia.ClinicalTrials.gov identifier: NCT01665586. Registered July 31, 2012.

SUBMITTER: Kim J

PROVIDER: S-EPMC4429489 | biostudies-literature | 2015 Jan

REPOSITORIES: biostudies-literature

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Adequate sedation with single-dose dexmedetomidine in patients undergoing transurethral resection of the prostate with spinal anaesthesia: a dose-response study by age group.

Kim Jeongmin J Kim Won Oak WO Kim Hye-Bin HB Kil Hae Keum HK

BMC anesthesiology 20150127

<h4>Background</h4>Dexmedetomidine (DMT), a highly selective α2-adrenoceptor agonist, has been used safely as a sedative in patients under regional anesthesia. The purpose of this study was to determine the 50% effective dose (ED50) of single-dose DMT to induce adequate light sedation in elderly patients in comparison with younger patients undergoing transurethral resection of the prostate (TURP) with spinal anesthesia.<h4>Methods</h4>Forty-two male patients were recruited. The young age group ( ...[more]

PMID: 25971886

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Project description:Dexmedetomidine (Precedex™) may be used as an alternative sedative in children, maintaining spontaneous breathing, and avoiding tracheal intubation in a non-intubated moderate or deep sedation (NI-MDS) approach. This open-label, single-arm, multicenter study evaluated the safety of dexmedetomidine in a pediatric population receiving NI-MDS in an operating room or a procedure room, with an intensivist or anesthesiologist in attendance, for elective diagnostic or therapeutic procedures expected to take at least 30 min. The primary endpoint was incidence of treatment-emergent adverse events (TEAEs). Patients received one of two doses dependent on age: patients aged ?28 weeks' gestational age to <1 month postnatal received dose level 1 (0.1 ?g/kg load; 0.05-0.2 ?g/kg/h infusion); those aged 1 month to <17 years received dose level 2 (1 ?g/kg load; 0.2-2.0 ?g/kg/h infusion). Sedation efficacy was assessed and defined as adequate sedation for at least 80% of the time and successful completion of the procedure without the need for rescue medication. In all, 91 patients were enrolled (dose level 1, n = 1; dose level 2, n = 90); of these, 90 received treatment and 82 completed the study. Eight patients in dose level 2 discontinued treatment for the following reasons: early completion of diagnostic or therapeutic procedure (n = 3); change in medical condition (need for intubation) requiring deeper level of sedation (n = 2); adverse event (AE; hives and emesis), lack of efficacy, and physician decision (patient not sedated enough to complete procedure; n = 1 each). Sixty-seven patients experienced 147 TEAEs. The two most commonly reported AEs were respiratory depression (bradypnea; reported per protocol-defined criteria, based on absolute respiratory rate values for age or relative decrease of 30% from baseline) and hypotension. Four patients received glycopyrrolate for bradycardia and seven patients received intravenous fluids for hypotension. SpO2 dropped by 10% in two patients, but resolved without need for manual ventilation. All other reported AEs were consistent with the known safety profile of dexmedetomidine. Two of the 78 patients in the efficacy-evaluable population met all sedation efficacy criteria. Dexmedetomidine was well-tolerated in pediatric patients undergoing procedure-type sedation.

Dataset Information

Adequate sedation with single-dose dexmedetomidine in patients undergoing transurethral resection of the prostate with spinal anaesthesia: a dose-response study by age group.

Publications

Adequate sedation with single-dose dexmedetomidine in patients undergoing transurethral resection of the prostate with spinal anaesthesia: a dose-response study by age group.

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