Postoperative Sleep Quality of Patients Sedation With i.v. Dexmedetomidine or Midazolam Undergoing TURP

Phase 4

Completed

• Conditions: Sleep Quality of Patients Undergoing TURP
• Interventions: Drug: Midazolam; Drug: dexmedetomidine

• Registration Number: NCT02142595
• Lead Sponsor: China Medical University, China

Brief Summary

The investigators designed a study to determine whether dexmedetomidine versus midazolam combined with spinal anesthesia would provide same postoperative sleep quality in patients undergoing transurethral prostatic resection.

Detailed Description

The investigators designed a study to determine whether dexmedetomidine versus midazolam combined with spinal anesthesia would provide same postoperative sleep quality in patients undergoing transurethral prostatic resection.The bispectral index score (BIS) was monitored during the operation and the first postoperative night

Study Timeline

• Status Verified: 2014-05
• Study Start: 2014-05
• Study First Submitted: 2014-05-15
• Study First Submitted QC: 2014-05-19
• Study First Posted: 2014-05-20
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Last Update Submitted: 2015-09-22
• Last Update Posted: 2015-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 111

Inclusion Criteria

• Participants were deemed eligible if they were candidates for spinal anesthesia undergoing TURP

Exclusion Criteria

• The exclusion criteria were body mass index exceeding 30 kg/m2, preoperative Pittsburgh Sleep Quality Index global scores higher than 6, anesthesia time longer than 3 hours, allergy to drugs used in the study and treatment with sedatives and analgesics during the postoperative BIS-Vista monitoring period.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Midazolam group M	Midazolam	The sedative solution was prepared as a 0.375mg/ml midazolam or normal saline in an unlabeled 20ml syringe. The sedative solution administered intravenously started at rate of kg (weight of patient)\*0.6 ml/h over a 10-min period and then at rate of kg (weight of patient)\*0.15 ml/h through syringe pump to the end of surgery
dexmeditomidine group D	dexmedetomidine	The sedative solution was prepared as a 10µg /ml dexmedetomidine in an unlabeled 20ml syringe. The sedative solution administered intravenously started at rate of kg (weight of patient)\*0.6 ml/h over a 10-min period and then at rate of kg (weight of patient)\*0.15 ml/h through syringe pump to the end of surgery

Primary Outcome Measures

Name	Time	Method
The Change of postoperative sleep quality	preoperation, first postoperative night	The bispectral index score (BIS) was monitored during the operation and the first postoperative night

Trial Locations

Locations (1)

the First Hospital of China Medical University; 🇨🇳 Shenyang, Liaoning, China