Sedation Complications in Urology During Spinal Anesthesia With Dexmedetomidine or Midazolam Regarding OSA Risk

Summary

Light to moderate sedation is recommended during surgery with spinal anesthesia . This study is exploring which sedation drug is better, midazolam or dexmedetomidine for transurethral resection of bladder and prostate in patients with or without high risk for obstructive sleep apnea (OSA). Patients were divided in two groups regarding OSA risk, and each group received midazolam or dexmedetomidine for sedation. Investigators observed intraoperative complications of airway and factors that are disturbing surgeon(movement due to participants coughing and restlessness) because one could puncture bladder or prostate and cause perforation.

Conditions

• Anesthesia
• Anesthesia Complication
• Osa Syndrome
• Transurethral Resection of Prostate
• Sedation Complication
• Intraoperative Complications
• Snoring
• Airway Obstruction

Interventions

PROCEDURE

Spinal anesthesia with intraoperative dexmedetomidine sedation

Skin was disinfected and 40mg of 2% Lidocaine was given subcutaneously at lumbar vertebrae 3/4 level. 25 G spinal needle was used and after dura and arachnoidea were pierced 12.5-15 mg of 0.5% Levobupivacaine was applied.

PROCEDURE

Spinal anesthesia with intraoperative midazolam sedation

Skin was disinfected and 40mg of 2% Lidocaine was given subcutaneously at lumbar vertebrae 3/4 level. 25 G spinal needle was used and after dura and arachnoidea were pierced 12.5-15 mg of 0.5% Levobupivacaine was applied.

DRUG

Dexmedetomidine

Dexmedetomidine 0.5 ug/kg during first 10 minutes after successful spinal anesthesia. Dose maintained to keep patient in moderate sedation with closed eyes and Ramsay sedation scale 4 and 5 level

DRUG

Midazolam

Midazolam 0.25 mg/kg ideal body weight during first 10 minutes after successful spinal anesthesia. Dose maintained to keep patient in moderate sedation with closed eyes and Ramsay sedation scale 4 and 5 level

Sponsors & Collaborators

• University Hospital of Split

  lead OTHER

Principal Investigators

• Ivan Vukovic · University Hospital Split, Department of Anesthesiology and Intensive Care, Split, Croatia

• Renata Pecotic · University of Split School of Medicine, Split, Croatia

• Bozidar Duplancic · University Hospital Split, Department of Anesthesiology and Intensive Care, Split, Croatia

• Benjamin Benzon · University of Split School of Medicine, Split, Croatia

• Zoran Dogas · University of Split School of Medicine, Split, Croatia

• Ruben Kovac · University Hospital Split, Department of Anesthesiology and Intensive Care, Split, Croatia

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-04-01

Primary Completion

2022-01-01

Completion

2022-02-01

Countries

• Croatia

Study Locations