Patients Undergoing Thyroid Surgery for NeoplasmNCT05016518

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

A study testing Arm I (Propofol group) and Arm II (Remimazolam group) in people with Patients Undergoing Thyroid Surgery for Neoplasm, run by Gangnam Severance Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 20 to 65 years, women only
Conditions the study is for: Patients Undergoing Thyroid Surgery for Neoplasm
What is being tested?: Arm I (Propofol group) and Arm II (Remimazolam group)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 140 participants
Where: 1 siteSouth Korea
Study dates: 16 Sep 2021to 20 May 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 65 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

1 site in 1 country.

South Korea1 site

Gangnam Severance Hospital
Seoul

Other trials in South Korea

About this study

Official title: Comparison of Quality of Recovery (QoR)-15 Scores According to the Use of Anesthetics During Total Intravenous Anesthesia in Female Patients Undergoing Thyroid Surgery

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.

Conditions: Patients Undergoing Thyroid Surgery for Neoplasm
Being tested: Arm I (Propofol group), Arm II (Remimazolam group)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Arm I (Propofol group)Drug
Propfol group will be started and maintained total intravenous anesthesia with propofol and remifentanil .
Arm II (Remimazolam group)Drug
Remimazolam group will be started and maintained total intravenous anesthesia with remimazolam and remifentanil.

Study groups in NCT05016518
Study group	Role	What they receive
Propofol group	Experimental	Propofol based total intravenous anesthesia Receives: Drug: Arm I (Propofol group)
Remimazolam group	Active comparator	Remimazolam based total intravenous anesthesia Receives: Drug: Arm II (Remimazolam group)

What is being measured

The primary outcome is the main question the study is designed to answer.

postoperative day 1(POD1) Quality of Recovery(QoR)-15 questionnaire score
Quality of life will be evaluated using Quality of Recovery(QoR)-15 questionnaire score at postoperative day 1(minimum value : 0, maximum value : 150, the higher the score, the better the result)
Measured: Postoperative day 1

Secondary outcomes (11)

postoperative day 2(POD2) Quality of Recovery(QoR)-15 questionnaire score
Quality of life will be evaluated using Quality of Recovery(QoR)-15 questionnaire score at postoperative day 2(minimum value : 0, maximum value : 150, the higher the score, the better the result)
Measured: Postoperative day 2
Response time
Time from cessation of main anaesthetics to patients' response to verbal command
Measured: perioperative - until 48hours
Tracheal extubation time
Time from cessation of main anaesthetics to tracheal extubation
Measured: perioperative - until 48hours
Time to recovery of self respiration
Time from cessation of main anaesthetics to recovery of spontaneous breathing
Measured: perioperative - until 48hours
PACU(post-anesthesia care unit) stay time
from entry of PACU to go general ward
Measured: perioperative - until 48hours
Postoperative pain score
postoperative pain score measured by 11-point NRS(numerical rating scale) score (minimum : 0, maximum : 11, the lower the score, the lesser pain)
Measured: at admission to PACU, discharge from PACU, postoperative 6hours
Postoperative nausea and vomiting
postoperative nausea and vomiting will be evaluated using 2 point scale (yes, no) at admission to PACU, discharge from PACU, postoperative 6hours
Measured: at admission to PACU, discharge from PACU, postoperative 6hours
Postoperative sedation score
monitored through the sedation scale called Richmond Agitation-Sedation Scale(RASS). RASS is a medical scale used to measure the agitation or sedation level of a person.The score ranges from +4 "combative" to -5 "unarousable".
Measured: at admission to PACU, discharge from PACU
the incidence of administration of postoperative rescue drug
administration of analgesic drug and anti-emetic drug for postoperative management
Measured: perioperative - until 72hours
hospital stay
days of hospital stay
Measured: preoperative - until discharge (usually 48 hours to 72hours)
postoperative complications
postoperative complications
Measured: preoperative - until discharge (usually 48 hours to 72hours)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Sep 202120 May 2022

First posted23 Aug 2021
Study start16 Sep 2021
Primary completion18 May 2022
Study completion20 May 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Patients Undergoing Thyroid Surgery for NeoplasmStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 140 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05016518
Sponsor's protocol ID: 2021-0424-002
Status last verified: May 2022
First submitted: 10 Aug 2021
Last updated: 1 Jun 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Quality of Recovery (QoR)-15 Scores According to the Use of Anesthetics During Total Intravenous Anesthesia in Female Patients Undergoing Thyroid Surgery
ClinicalTrials.gov ID: NCT05016518
Acronym / sponsor ID: 2021-0424-002
Conditions: Patients Undergoing Thyroid Surgery for Neoplasm
Study type: Interventional
Recruitment status: Completed
Enrolment: 140 participants (actual)
Lead sponsor: Gangnam Severance HospitalUniversity, hospital or other
Study start: 16 Sep 2021 (actual)
Primary completion: 18 May 2022 (actual)
Study completion: 20 May 2022 (actual)
First posted: 23 Aug 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Propofol group	Experimental	Drug: Arm I (Propofol group)Propofol based total intravenous anesthesia
Remimazolam group	Active comparator	Drug: Arm II (Remimazolam group)Remimazolam based total intravenous anesthesia

Who may qualify

Ages: 20 to 65 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Arm I (Propofol group)Propfol group will be started and maintained total intravenous anesthesia with propofol and remifentanil .	Drug	Propofol group
Arm II (Remimazolam group)Remimazolam group will be started and maintained total intravenous anesthesia with remimazolam and remifentanil.	Drug	Remimazolam group

Primary outcome

postoperative day 1(POD1) Quality of Recovery(QoR)-15 questionnaire score
Time frame: Postoperative day 1
Quality of life will be evaluated using Quality of Recovery(QoR)-15 questionnaire score at postoperative day 1(minimum value : 0, maximum value : 150, the higher the score, the better the result)

11 secondary outcomes

postoperative day 2(POD2) Quality of Recovery(QoR)-15 questionnaire score
Time frame: Postoperative day 2
Response time
Time frame: perioperative - until 48hours
Tracheal extubation time
Time frame: perioperative - until 48hours
Time to recovery of self respiration
Time frame: perioperative - until 48hours
PACU(post-anesthesia care unit) stay time
Time frame: perioperative - until 48hours
Postoperative pain score
Time frame: at admission to PACU, discharge from PACU, postoperative 6hours
Postoperative nausea and vomiting
Time frame: at admission to PACU, discharge from PACU, postoperative 6hours
Postoperative sedation score
Time frame: at admission to PACU, discharge from PACU
the incidence of administration of postoperative rescue drug
Time frame: perioperative - until 72hours
hospital stay
Time frame: preoperative - until discharge (usually 48 hours to 72hours)
postoperative complications
Time frame: preoperative - until discharge (usually 48 hours to 72hours)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Young Song principal investigator

GangnamSeverance Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Arm I (Propofol group) and Arm II (Remimazolam group) in people with Patients Undergoing Thyroid Surgery for Neoplasm, run by Gangnam Severance Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

postoperative day 1(POD1) Quality of Recovery(QoR)-15 questionnaire score (time frame: Postoperative day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05016518.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2022.