Comparison of intravenous remimazolam and dexmedetomidine for sedation in patients undergoing surgery under spinal anesthesia

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0007547

Enrollment

Registered

2022-07-25

Start date

2022-07-22

Completion date

Unknown

Last updated

2022-09-20

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

Conditions

None listed

Interventions

Drug : When entering the operating room, an electrocardiogram, non-invasive blood pressure monitor, oxygen saturation meter, and BIS(bispectral index) monitor are placed. After standard monitoring, 5

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - American Society of Anesthesiologists physical status classification I, II, or III. - Patients aged 20 to 80 who agreed to participate in the study. - Patients undergoing surgery under spinal anesthesia performed at Dona-A university hospital

Exclusion criteria

Exclusion criteria: - Patients with hypersensitivity to remimazolam and other benzodiazepines and to dexmedetomidine. - Patients with puncture site infection. - Patients with bleeding tendency. - Patients with a history of spinal surgery. - Patients with severe spinal deformity or spinal stenosis. - Emergency operation. - Patients with morbid obesity(BMI >35) - Patients who are in the intensive care unit or who are scheduled to be transferred to the intensive care unit after surgery. - Maternity or lactating woman. - Patients who are unable to communicate and have cognitive impairment. - patient's refusal

Design outcomes

Primary

Measure	Time frame
Frequency of intraoperative and postoperative bradycardia	—

Secondary

Measure	Time frame
Changes in vital signs during intraoperative and postoperative period;Changes in the depth of sedation during intraoperative and postoperative period;Frequency of intraoperative and postoperative hypotension;Frequency of intraoperative and postoperative desaturation;atropine usage during intraoperative and postoperative period;ephedrine usage during intraoperative and postoperative period;time required to awakening after cessation of sedation;time required to recovery after cessation of sedation;PACU(Post Anesthesia Care Unit) stay time;time required to recovery of sensory block;postsedative shivering;postsedative pruritus;postsedative nausea and vomiting;postsedative pain;postsedative headache;postsedative dizziness;postsedative respiratory depression;time of first urination after operation	—

Measure

Time frame

Changes in vital signs during intraoperative and postoperative period;Changes in the depth of sedation during intraoperative and postoperative period;Frequency of intraoperative and postoperative hypotension;Frequency of intraoperative and postoperative desaturation;atropine usage during intraoperative and postoperative period;ephedrine usage during intraoperative and postoperative period;time required to awakening after cessation of sedation;time required to recovery after cessation of sedation;PACU(Post Anesthesia Care Unit) stay time;time required to recovery of sensory block;postsedative shivering;postsedative pruritus;postsedative nausea and vomiting;postsedative pain;postsedative headache;postsedative dizziness;postsedative respiratory depression;time of first urination after operation

—

Countries

Korea, Republic of

Contacts

Public ContactJi Wook Jung

Dong-A University Hospital

wnr2749@gmail.com+82-51-240-5390

Outcome results