Comparison of Remimazolam and Dexmedetomidine for Intraoperative Sedation

Sponsor

Seoul National University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05447507

Collaborator

(none)

104

Enrollment

Location

Arms

11.7

Anticipated Duration (Months)

8.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Orthopedic Disorder	Drug: Remimazolam Drug: Dexmedetomidine	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

104 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

Comparison of Remimazolam and Dexmedetomidine for Intraoperative Sedation During Regional Block

Actual Study Start Date :

Jul 8, 2022

Anticipated Primary Completion Date :

Jan 30, 2023

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Remimazolam	Drug: Remimazolam 0.075 mg/kg Remimazolam bolus infusion for 1 min, then 0.5~1.0 mg/kg/h continuous infusion
Active Comparator: Dexmedetomidine	Drug: Dexmedetomidine 1 mcg/kg Dexmedetomidine infusion for 10 min, then 0.2~0.7 mcg/kg/h continuous infusion

Arm

Intervention/Treatment

Active Comparator: Remimazolam

Drug: Remimazolam

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

Active Comparator: Dexmedetomidine

Drug: Dexmedetomidine

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

Outcome Measures

Primary Outcome Measures

Number of rescue sedative doses administered [Intraoperative period]

Secondary Outcome Measures

Incidence of intraoperative bradycardia (heart rate lower than 45 bpm) [Intraoperative period]
Incidence of intraoperative hypotension (mean blood pressure lower than 65 mmHg or systolic blood pressure lower than 80% of baseline) [Intraoperative period]
Incidence of intraoperative hypertension (systolic blood pressure higher than 120% of baseline) [Intraoperative period]
Incidence of respiratory depression (respiratory rate lower than 8 per minute) [Intraoperative period]
Incidence of hypoxia (oxygen saturation detected by pulse oxymetry less than 93%) [Intraoperative period]
MOAA/S score (Modified Observer's Assessment of Alertness and Sedation, 0=unarousable, 5=alert) [Intraoperative period]
Intraoperative PSi (Patient State index) [Intraoperative period]
Electroencephalogram data (alpha, beta, delta, theta waves) [Intraoperative period]
Time to reach MOAA/S = 5 after end of drug infusion [Intraoperative period and post-anesthesia care period (immediate post-operative period)]
Oxygen supply at the post-anesthesia care unit [Post-anesthesia care period (immediate post-operative period)]
Incidence of postoperative delirium [Immediately after the surgery, up to 5 days after surgery]
Incidence of nausea/vomiting [Intraoperative period and post-anesthesia care period (immediate post-operative period)]
Postoperative spinal anesthesia block level [Postoperative period, up to 12h hours after end of surgery]
Duration of stay in the post-anesthsia care unit(PACU) [Immediate postoperative period]
Patient satisfaction (numerical rating scale of 0~10) [Immediately after the surgery, up to 5 days after surgery]
0 Not at all satisfied, 10 very satisfied
Serum CRP level [Preoperative baseline and second postoperative day]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul	Jongno-gu	Korea, Republic of	03080

Sponsors and Collaborators

Seoul National University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jin-Tae Kim, Professor, Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT05447507

Other Study ID Numbers:

2205-011-1320

First Posted:

Jul 7, 2022

Last Update Posted:

Jul 28, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

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.:

Additional relevant MeSH terms:

Musculoskeletal Diseases

Dexmedetomidine

Study Results

No Results Posted as of Jul 28, 2022