Clinical trial NCT05447507: Comparison of Remimazolam and Dexmedetomidine for Intraoperative Sedation
Official title: Comparison of Remimazolam and Dexmedetomidine for Intraoperative Sedation During Regional Block
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Orthopedic Disorder
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2022-07-07
Enrollment: 104
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Number of rescue sedative doses administered
timeFrame: Intraoperative period
Secondary outcomes:
measure: Incidence of intraoperative bradycardia (heart rate lower than 45 bpm)
timeFrame: Intraoperative period
measure: Incidence of intraoperative hypotension (mean blood pressure lower than 65 mmHg or systolic blood pressure lower than 80% of baseline)
timeFrame: Intraoperative period
measure: Incidence of intraoperative hypertension (systolic blood pressure higher than 120% of baseline)
timeFrame: Intraoperative period
measure: Incidence of respiratory depression (respiratory rate lower than 8 per minute)
timeFrame: Intraoperative period
measure: Incidence of hypoxia (oxygen saturation detected by pulse oxymetry less than 93%)
timeFrame: Intraoperative period
measure: MOAA/S score (Modified Observer's Assessment of Alertness and Sedation, 0=unarousable, 5=alert)
timeFrame: Intraoperative period
measure: Intraoperative PSi (Patient State index)
timeFrame: Intraoperative period
measure: Electroencephalogram data (alpha, beta, delta, theta waves)
timeFrame: Intraoperative period
measure: Time to reach MOAA/S = 5 after end of drug infusion
timeFrame: Intraoperative period and post-anesthesia care period (immediate post-operative period)
measure: Oxygen supply at the post-anesthesia care unit
timeFrame: Post-anesthesia care period (immediate post-operative period)
measure: Incidence of postoperative delirium
timeFrame: Immediately after the surgery, up to 5 days after surgery
measure: Incidence of nausea/vomiting
timeFrame: Intraoperative period and post-anesthesia care period (immediate post-operative period)
measure: Postoperative spinal anesthesia block level
timeFrame: Postoperative period, up to 12h hours after end of surgery
measure: Duration of stay in the post-anesthsia care unit(PACU)
timeFrame: Immediate postoperative period
measure: Patient satisfaction (numerical rating scale of 0~10)
timeFrame: Immediately after the surgery, up to 5 days after surgery
measure: Serum CRP level
timeFrame: Preoperative baseline and second postoperative day
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Jongno-gu
Study officials:
References: