NCT05577962

Brief Summary

To analyze and compare the effect of OFA scheme and traditional balanced anesthesia scheme on QoR15 after thyroidectomy, and further clarify the safety and rationality of OFA scheme in perioperative application of thyroid surgery.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for phase_4

Timeline
2mo left

Started Aug 2024

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress90%
Aug 2024Dec 2026

First Submitted

Initial submission to the registry

October 7, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 13, 2022

Completed
1.8 years until next milestone

Study Start

First participant enrolled

August 1, 2024

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Expected
Last Updated

August 5, 2026

Status Verified

June 1, 2026

Enrollment Period

2.2 years

First QC Date

October 7, 2022

Last Update Submit

August 3, 2026

Conditions

Opioid-free Anesthesia

Keywords

thyroidectomythe early quality of recovery

Outcome Measures

Primary Outcomes (1)

  • The QoR-15 score

    The quality of recovery-15 score,The QoR was classified as excellent (QoR-15 \> 135), good (122 ≤ QoR-15 ≤ 135), moderate (90 ≤ QoR-15 ≤ 121) or poor (QoR-15 \< 90).

    Hour 24 after surgery

Secondary Outcomes (8)

  • Postoperative VAS score

    Hour 24，Hour 48，Hour 72 after surgery

  • Postoperative complication rate

    Hour 24，Hour 48，Hour 72 after surgery

  • Opioid consumption

    Hour 24，Hour 48，Hour 72 after surgery

  • Anesthesia related adverse events

    Hour 24，Hour 48，Hour 72 after surgery

  • Postoperative fatigue, ICFS scores after surgery

    Hour 24，Hour 48，Hour 72 after surgery

  • +3 more secondary outcomes

Study Arms (2)

C group

NO INTERVENTION

opioid-based anesthesia

T group

EXPERIMENTAL

Opioid-free Anesthesia

Drug: OFA group (group T)

Interventions

OFA group (group T)DRUG

OFA scheme (group T) was given dexamethasone 8mg for anti-inflammatory and antiemetic before operation, flurbiprofen axetil 50mg for preemptive analgesia, and dexmedetomidine was infused under ECG monitoring at an initial rate of 0.5 μ G/kg (more than 10min), then changed to 0.2ug/kg/h, and stopped infusion 20 minutes before operation closure. Before induction, lidocaine (1mg/kg), esketamine (0.5mg/kg), propofol (1-2mg/kg) and rocuronium (0.6mg/kg) were infused slowly, and endotracheal intubation was carried out when the anesthetic was fully effective and the BIS value was about 40. After successful intubation.During the operation, continuous propofol (BIS-guided) plus dexmedetomidine 0.2 μg/kg/h (stopped 20 min before skin closure) plus lidocaine 1 mg/kg/h was used to maintain the depth of anesthesia;

T group

Eligibility Criteria

Age18 Years - 99 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing elective thyroidectomy under general anesthesia
  • \>18 year old
  • The informed consent form has been signed
  • American Society of Anesthesiologists (ASA) anesthesia grade I - II

You may not qualify if:

  • Long term use of opioids
  • Long term use of NSAIDs
  • Have a history of psychosis, epilepsy, preoperative anxiety, depression, and emotional management disorders
  • Patients with increased gastric contents reflux and respiratory tract aspiration
  • Operation time\>3h
  • Severe liver and kidney insufficiency, cardiac insufficiency, bradycardia with 2 ° II or 3° atrioventricular block
  • Those who are allergic to or have contraindications to drugs that may be used in the test
  • Those who cannot cooperate with researchers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

RECRUITING

MeSH Terms

Interventions

Sensitivity Training Groups

Intervention Hierarchy (Ancestors)

Psychotherapy, GroupSocioenvironmental TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Haijun Hou

    Guang'anmen Hospital of China Academy of Chinese Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Haijun Hou

CONTACT

+8618612568228lumen208@foxmail.com

lu liu

CONTACT

+8618618418228emmaliulu@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2022

First Posted

October 13, 2022

Study Start

August 1, 2024

Primary Completion

October 1, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

August 5, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)