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Comparison of Remimazolam and Dexmedetomidine for Intraoperative Sedation

Primary Purpose

Orthopedic Disorder

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Remimazolam

Dexmedetomidine

About this trial

This is an interventional treatment trial for Orthopedic Disorder

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Patient scheduled for lower extremity surgery under regional anesthesia, aged 19-70, of ASA class I or II.

Exclusion Criteria:

Patient refusal
Contraindications to regional or neuraxial anesthesia (patient refusal, increased intracranial pressure, infection at puncture site, underlying neurologic disease, severe hypovolemia, aortic or mitral stenosis, thrombocytopenia or coagulopathy)
Contraindications to dexmedetomidine or remimazolam administration
Allergy to dexmedetomidine or remimazolam
Baseline MOAA/S score of 4 or less
Pregnancy
Other conditions considered unsuitable by the investigators

Sites / Locations

Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Remimazolam

Dexmedetomidine

Arm Description

Outcomes

Primary Outcome Measures

Number of rescue sedative doses administered

Secondary Outcome Measures

Incidence of intraoperative bradycardia (heart rate lower than 45 bpm)

Incidence of intraoperative hypotension (mean blood pressure lower than 65 mmHg or systolic blood pressure lower than 80% of baseline)

Incidence of intraoperative hypertension (systolic blood pressure higher than 120% of baseline)

Incidence of respiratory depression (respiratory rate lower than 8 per minute)

Incidence of hypoxia (oxygen saturation detected by pulse oxymetry less than 93%)

MOAA/S score (Modified Observer's Assessment of Alertness and Sedation, 0=unarousable, 5=alert)

Intraoperative PSi (Patient State index)

Electroencephalogram data (alpha, beta, delta, theta waves)

Time to reach MOAA/S = 5 after end of drug infusion

Oxygen supply at the post-anesthesia care unit

Incidence of postoperative delirium

Incidence of nausea/vomiting

Postoperative spinal anesthesia block level

Duration of stay in the post-anesthsia care unit(PACU)

Patient satisfaction (numerical rating scale of 0~10)

0 Not at all satisfied, 10 very satisfied

Serum CRP level

Full Information

NCT ID

NCT05447507

First Posted

June 21, 2022

Last Updated

November 22, 2022

Sponsor

Seoul National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05447507

Brief Title

Comparison of Remimazolam and Dexmedetomidine for Intraoperative Sedation

Official Title

Comparison of Remimazolam and Dexmedetomidine for Intraoperative Sedation During Regional Block

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Completed

Study Start Date

July 8, 2022 (Actual)

Primary Completion Date

October 26, 2022 (Actual)

Study Completion Date

October 26, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to compare the sedation efficacy of dexmedetomidine and remimazolam for intraoperative sedation during regional block.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Orthopedic Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

104 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Remimazolam

Arm Type

Active Comparator

Arm Title

Dexmedetomidine

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Remimazolam

Intervention Description

0.075 mg/kg Remimazolam bolus infusion for 1 min, then 0.5~1.0 mg/kg/h continuous infusion

Intervention Type

Drug

Intervention Name(s)

Dexmedetomidine

Intervention Description

1 mcg/kg Dexmedetomidine infusion for 10 min, then 0.2~0.7 mcg/kg/h continuous infusion

Primary Outcome Measure Information:

Title

Number of rescue sedative doses administered

Time Frame

Intraoperative period

Secondary Outcome Measure Information:

Title

Incidence of intraoperative bradycardia (heart rate lower than 45 bpm)

Time Frame

Intraoperative period

Title

Incidence of intraoperative hypotension (mean blood pressure lower than 65 mmHg or systolic blood pressure lower than 80% of baseline)

Time Frame

Intraoperative period

Title

Incidence of intraoperative hypertension (systolic blood pressure higher than 120% of baseline)

Time Frame

Intraoperative period

Title

Incidence of respiratory depression (respiratory rate lower than 8 per minute)

Time Frame

Intraoperative period

Title

Incidence of hypoxia (oxygen saturation detected by pulse oxymetry less than 93%)

Time Frame

Intraoperative period

Title

MOAA/S score (Modified Observer's Assessment of Alertness and Sedation, 0=unarousable, 5=alert)

Time Frame

Intraoperative period

Title

Intraoperative PSi (Patient State index)

Time Frame

Intraoperative period

Title

Electroencephalogram data (alpha, beta, delta, theta waves)

Time Frame

Intraoperative period

Title

Time to reach MOAA/S = 5 after end of drug infusion

Time Frame

Intraoperative period and post-anesthesia care period (immediate post-operative period)

Title

Oxygen supply at the post-anesthesia care unit

Time Frame

Post-anesthesia care period (immediate post-operative period)

Title

Incidence of postoperative delirium

Time Frame

Immediately after the surgery, up to 5 days after surgery

Title

Incidence of nausea/vomiting

Time Frame

Intraoperative period and post-anesthesia care period (immediate post-operative period)

Title

Postoperative spinal anesthesia block level

Time Frame

Postoperative period, up to 12h hours after end of surgery

Title

Duration of stay in the post-anesthsia care unit(PACU)

Time Frame

Immediate postoperative period

Title

Patient satisfaction (numerical rating scale of 0~10)

Description

0 Not at all satisfied, 10 very satisfied

Time Frame

Immediately after the surgery, up to 5 days after surgery

Title

Serum CRP level

Time Frame

Preoperative baseline and second postoperative day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient scheduled for lower extremity surgery under regional anesthesia, aged 19-70, of ASA class I or II. Exclusion Criteria: Patient refusal Contraindications to regional or neuraxial anesthesia (patient refusal, increased intracranial pressure, infection at puncture site, underlying neurologic disease, severe hypovolemia, aortic or mitral stenosis, thrombocytopenia or coagulopathy) Contraindications to dexmedetomidine or remimazolam administration Allergy to dexmedetomidine or remimazolam Baseline MOAA/S score of 4 or less Pregnancy Other conditions considered unsuitable by the investigators

Facility Information:

Facility Name

Seoul National University Hospital

City

Seoul

State/Province

Jongno-gu

ZIP/Postal Code

03080

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Comparison of Remimazolam and Dexmedetomidine for Intraoperative Sedation

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