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

NCT ID: NCT05016518

Last Updated: 2022-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-16

Study Completion Date

2022-05-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Patients Undergoing Thyroid Surgery for Neoplasm

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Propofol group

Propofol based total intravenous anesthesia

Group Type EXPERIMENTAL

Arm I (Propofol group)

Intervention Type DRUG

Propfol group will be started and maintained total intravenous anesthesia with propofol and remifentanil .

Remimazolam group

Remimazolam based total intravenous anesthesia

Group Type ACTIVE_COMPARATOR

Arm II (Remimazolam group)

Intervention Type DRUG

Remimazolam group will be started and maintained total intravenous anesthesia with remimazolam and remifentanil.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Arm I (Propofol group)

Propfol group will be started and maintained total intravenous anesthesia with propofol and remifentanil .

Intervention Type DRUG

Arm II (Remimazolam group)

Remimazolam group will be started and maintained total intravenous anesthesia with remimazolam and remifentanil.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Gangnam Severance Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Young Song

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Young Song

Role: PRINCIPAL_INVESTIGATOR

GangnamSeverance Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Gangnam Severance Hospital

Seoul, , South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2021-0424-002

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.