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

China Medical University, China

Status and phase: Completed; Phase 4

Conditions: Sleep Quality of Patients Undergoing TURP

Treatments: Drug: Midazolam; Drug: dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT02142595

20140515

Details and patient eligibility

About

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.

Full 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

Enrollment: 111 patients

Sex: Male

Ages: 60 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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111 participants in 3 patient groups

dexmeditomidine group D

Experimental group

Description:

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

Treatment:

Drug: dexmedetomidine

Midazolam group M

Experimental group

Description:

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

Treatment:

Drug: Midazolam

group control

No Intervention group

Description:

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