Comparison of dexmedetomidine and remimazolam in conscious sedation for percutaneous thermal ablation of liver tumor: a randomized controlled study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0008873

Enrollment

Registered

2023-10-16

Start date

2023-10-17

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Dexmedetomidine Group: Dexmedetomidine 0.5 mcg/kg is administered over 10 minutes, followed by maintenance at 0.5 mcg/kg/hr. Remimazolam Group: 1 mg is administered over 15 seconds upon needle

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: conscious sedation for percutaneous thermal ablation of liver tumor ASA class I - III

Exclusion criteria

Exclusion criteria: 1) contraindicated for benzodiazepine-class medication administration (e.g., patients with a known allergy to the drug or a history of hypersensitivity reactions). 2) the patient refuses

Design outcomes

Primary

Measure	Time frame
Patient satisfaction was expressed by the PSSI	—

Secondary

Measure	Time frame
Satisfaction of interventionist (1 : Very dissatisfied ~ 5 : Very satisfied);Satisfaction of anesthesiologist (by CSSI questionnaire);Hemodynamic stability (incidence of hypotension(MBP100mmHg) or bradycardia (<45beats/min), use of drugs);Adverse effect related procedure (Failure of complete ablation - CT findings, hemorrhage(;Sedation level (MOAA/S scale);Time to Respond After Procedure Completion;Dosage of drugs (dexmedetomidine, remimazolam, remifentanil);conscious level in recovery room (RASS);pain score (NRS 0-10);Nause and vomiting (0:none 1:mild 2:moderate 3:severe);Level of memory recall during the procedure	—

Measure

Time frame

Satisfaction of interventionist (1 : Very dissatisfied ~ 5 : Very satisfied);Satisfaction of anesthesiologist (by CSSI questionnaire);Hemodynamic stability (incidence of hypotension(MBP100mmHg) or bradycardia (<45beats/min), use of drugs);Adverse effect related procedure (Failure of complete ablation - CT findings, hemorrhage(;Sedation level (MOAA/S scale);Time to Respond After Procedure Completion;Dosage of drugs (dexmedetomidine, remimazolam, remifentanil);conscious level in recovery room (RASS);pain score (NRS 0-10);Nause and vomiting (0:none 1:mild 2:moderate 3:severe);Level of memory recall during the procedure

—

Countries

Korea, Republic of

Contacts

Public ContactSeungwon Lee

Samsung Medical Center

seungwon0209.lee@samsung.com+82-2-3410-0369

Outcome results