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

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

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
4 months until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

October 13, 2022

Status Verified

October 1, 2022

Enrollment Period

8 months

First QC Date

October 7, 2022

Last Update Submit

October 9, 2022

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，Hour 48，Hour 72 after surgery

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (2)

C group

NO INTERVENTION

The routine anesthesia group

T group

EXPERIMENTAL

Opioid-free Anesthesia

Drug: T group

Interventions

T groupDRUG

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, an experienced anesthesiologist guided by ultrasound performed bilateral superficial cervical plexus block with 0.5% ropivacaine and injected 3-4ml at two points respectively; During the operation, sevoflurane (MAC1.0 - 1.4) 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)

Haijun Hou

Beijing, 100050, China

Location

MeSH Terms

Interventions

Sensitivity Training Groups

Intervention Hierarchy (Ancestors)

Psychotherapy, GroupSocioenvironmental TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Haijun Hou

    Beijing Friendship Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Haijun Hou

CONTACT

+8618612568228lumen208@foxmail.com

lu liu

CONTACT

+8618618418228emmaliulu@163.com

Study Design

Study Type
interventional
Phase
not applicable
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

February 1, 2023

Primary Completion

September 30, 2023

Study Completion

December 31, 2023

Last Updated

October 13, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)