Comparison of Postoperative QoR-15 Scores Between Propofol and Remimazolam

Patients Undergoing Spine Surgery Clinical Trial

Official title:

Comparison of Postoperative Quality of Recovery (QoR)-15 Scores According to the Use of Anesthetics (Propofol vs. Remimazolam) During Total Intravenous Anesthesia in the Spine Surgery Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04994704
• Other study ID #: 3-2021-0216
• Status: Completed
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: July 12, 2023

Study information

• Verified date: July 2023
• Source: Gangnam Severance Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Remimazolam is a ultra-short-acting benzodiazepine, and unlike conventional benzodiazepine drugs, it is rapidly metabolized in plasma and not accumulates in the body for long periods of infusion or even with high dose administration. In addition, it has no injection pain and infusion syndrome compared with propofol. In particular, there is no study to investigate overall postoperative functional recovery via QoR-15 in patients receiving TIVA using remimazolam. Therefore, rhe purpose of the study is to compare poetoperative quality of recovery (QoR)-15 scores according to the use of anesthetics for total intravenous anesthesia in the cervical spine surgery with intraoperative neurophysiological monitoring.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: July 12, 2023
• Est. primary completion date: July 12, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• Adult patients who aged 20-70 years with ASA-PS 1-3,

• diagnosed of ossification of the posterior longitudinal ligament or cervical spondylotic myelopathy

• intraoperative neurophysiological monitoring.

Exclusion Criteria:

• Tolerance or hypersensitivity to benzodiazepine or propofol

• Dependence or addiction to psychotropic drugs or alcohol

• Pregnant women, subjects who lack the ability to make decisions and susceptible to voluntary participation decisions

Related Conditions & MeSH terms

• Patients Undergoing Spine Surgery

Intervention

Drug:
• Propfol group
Propfol group will be started and maintained total intravenous anesthesia with propofol and remifentanil under target controlled infusion (TCI) model.
• Remimazolam group
Remimazolam group will be started total intravenous anesthesia with remiamazolam at 6 mg/kg/h for induction, and maintained at 0.5-1.5 mg/kg/h and remifentanil under TCI model.

Locations

Country	Name	City	State
Korea, Republic of	GangnamSeverance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Gangnam Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference of QoR-15 scores between two groups (propofol vs. remimazolam)	The difference of scores in the Quality of Recovery (QoR)-15 survey.Minimum value: 0, Maximum value: 150, higher scores means better.	postoperative day 1