Comparison of postoperative nausea and vomiting between remimazolam and sevoflurane in middle ear surgery

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0006975

Enrollment

Registered

2022-02-03

Start date

2022-01-28

Completion date

Unknown

Last updated

2022-02-07

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 esophageal thermometer are installed. To evaluate the depth of sedation

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 in Dong-A university hospital.

Exclusion criteria

Exclusion criteria: - Patients with hypersensitivity to Remimazolam and other benzodiazepines. - Emergency operation. - Patients with morbid obesity. (BMI >35) - Patients in the intensive care unit or previously scheduled to be transferred to the intensive care unit after surgery. - Maternity or lactating club. - Patients who are unable to communicate and have cognitive impairment. - Patients whose bispectral index is not adjusted to between 40 and 60 even after 30 minutes from the start of surgery. - Patient's refusal.

Design outcomes

Primary

Measure	Time frame
Postoperative nausea and vomiting within 12 hours after surgery	—

Secondary

Measure	Time frame
Postoperative nausea and vomiting within 12 to 24 hours after surgery ;Postoperative nausea and vomiting within 24 to 48 hours after surgery ;Antiemetics rescue;Time of the first request for antiemetics ;Postoperative pain;Postoperative pain rescue; Time of the first request for painkiller;Postoperative headache;Postoperative dizziness;Postoperative respiratory depression;Postoperative sleep disorder;Postoperative amnesia;Postoperative delirium;Changes in intraoperative vital signs;Changes in depth of anesthesia during surgery;Incidence of intraoperative hypotension ;Incidence of intraoperative bradycardia or tachycardia;Incidence of intraoperative decreases in SpO2;Time required to eye opening after cessation of anesthetics;Time required to extubation after cessation of anesthetics;Time required to cooperation after cessation of anesthetics;Time required to Aldrete score 9 or more after cessation of anesthetics;PACU(Post Anesthesia Care Unit) stay time;Hospital stay time;Amount of remifentanil used intraoperatively	—

Measure

Time frame

Postoperative nausea and vomiting within 12 to 24 hours after surgery ;Postoperative nausea and vomiting within 24 to 48 hours after surgery ;Antiemetics rescue;Time of the first request for antiemetics ;Postoperative pain;Postoperative pain rescue; Time of the first request for painkiller;Postoperative headache;Postoperative dizziness;Postoperative respiratory depression;Postoperative sleep disorder;Postoperative amnesia;Postoperative delirium;Changes in intraoperative vital signs;Changes in depth of anesthesia during surgery;Incidence of intraoperative hypotension ;Incidence of intraoperative bradycardia or tachycardia;Incidence of intraoperative decreases in SpO2;Time required to eye opening after cessation of anesthetics;Time required to extubation after cessation of anesthetics;Time required to cooperation after cessation of anesthetics;Time required to Aldrete score 9 or more after cessation of anesthetics;PACU(Post Anesthesia Care Unit) stay time;Hospital stay time;Amount of remifentanil used intraoperatively

—

Countries

Korea, Republic of

Contacts

Public ContactJi Wook Jung

Dong-A University Hospital

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

Outcome results