Skip to main content
OpenTrials
Completed

NCT Number: NCT05305248

Sedation With Remimazolam During Spinal Anesthesia

Remimazolam is a benzodiazepine-binding site antagonist of the GABA receptor, metabolized by esterases, and exhibits a stable context-sensitive half-life of 6-7 minutes. Remimazolam has a high clearance rate and a small volume of distribution in the pharmacokinetic model. The US FDA has approved sedation for surgery. Although there have been studies on the use of remimazolam as a sedative for procedures such as endoscopy, there have been no reports of the use of remimazolam in spinal anesthesia. The purpose of this study is to compare and analyze the hemodynamics and recovery profile of patients undergoing surgery under spinal anesthesia by maintaining sedation with dexmedetomidine or remimazolam.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sedation Spinal Anesthesia

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gangnam Severance Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Severe cardiovascular or respiratory disease
  • Contraindication to spinal anesthesia
  • Heart block
  • Previous hepatectomy or liver transplant
  • Patients with moderate or more hepatic impairment (AST/ALT is more than 2.5 times the upper limit of normal)
  • Estimated glomerular filtration rate < 30 mL/min/1.73m2
  • Acute narrow angle glaucoma
  • Myasthesia gravis
  • Known allergy to the drugs included in the study

Exclusion criteria

  • Patients 19 years of age or older who are expected to elective orthopedic surgery under spinal anaesthesia
  • ASA PS 1-3

Treatment and study plan

Remimazolam

Drug

After spinal anesthesia, 5 mg of remimazolam is injected by intravenous route for 1 minute to induce sedation. To maintain sedation, remimazolam is continuously infused at a rate within the range of 0.1 mg/kg/h to 1 mg/kg/h.

Dexmedetomidine

Drug

After performing spinal anesthesia, dexmedetomidine is injected at a loading dose of 1 mcg/kg for 10 minutes to induce sedation. Thereafter, to maintain sedation, Dexmedetomidine is continuously infused at a rate within the range of 0.2 to 0.7 mcg/kg/h.

Primary outcomes

  1. MOAA/S score

    Time frame: up to 30 minutes after PACU arrival

    MOAA/S score will be evaluated by an 5-point scale from iniation of sedative drugs to 30 minutes after PCAU arrival at 10 minutes intervals.

Secondary outcomes

  1. Sedation induction time Sedation induction time

    Time frame: up to 5 minutes after initation of sedative drugs

    Sedation induction time is defined as from start of drug injection to the first time of MOAA/S ≤ 3

  2. Differences in basic vital signs between the two groups

    Time frame: Baseline

    Differences in blood pressure, heart rate, and patient sedation index at different time points during the operation and PACU stay between the two groups

Sponsors and collaborators

Lead sponsor

Gangnam Severance Hospital

Other

Registry information

Official study title

Comparison of Sedation With Intravenous Remimazolam and Dexmedetomidine During Spinal Anesthesia : Prospective Randomized Study

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 31, 2022
Registry last updated
May 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.