Comparison of Quality of Recovery (QoR)-15 Scores Between Propofol and Remimazolam Anesthesia

Yonsei University Health System (YUHS)

Status: Completed

Conditions: Patients Undergoing Thyroid Surgery for Neoplasm

Treatments: Drug: Arm II (Remimazolam group); Drug: Arm I (Propofol group)

Study type: Interventional

Funder types: Other

Identifiers

NCT05016518

2021-0424-002

Details and patient eligibility

About

Remimazolam is a ultra-short-acting benzodiazepine that is rapidly metabolized in the body by tissue esterase and not accumulates in the body for long periods of infusion. In addition, similar to other benzodiazepines, it is possible to reverse the sedation and anesthetic effects through flumazenil. It has no injection pain and infusion syndrome compared with propofol. There is no study to investigate overall postoperative functional recovery via QoR-15 in patients receiving TIVA using remimazolam. The purpose of this study is to determine whether there is any difference in the quality of postoperative recovery between propofol-based and remimazolam-based total intravenous anesthesia in female patients undergoing thyroidectomy. The QoR-15 questionnaire score, pain, nausea/vomiting, and the frequency of complications are evaluated and compared between the two groups.

Enrollment: 140 patients

Sex: Female

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

•20≤Age≤65 female Open thyroidectomy ASA-PS I-III

Exclusion criteria

• Allergic history of any study drug
• Taking any sedative, opioid, or sleep aid drugs
• Psychiatric or neurological disorder
• BMI>30 kg/m2
• Pregnancy
• Vulnerable patients

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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140 participants in 2 patient groups

Propofol group

Experimental group

Description:

Propofol based total intravenous anesthesia

Treatment:

Drug: Arm I (Propofol group)

Remimazolam group

Active Comparator group

Description:

Remimazolam based total intravenous anesthesia

Treatment:

Drug: Arm II (Remimazolam group)