Opioid Free Anesthesia on the Quality of Early Recovery

Not Applicable

Not yet recruiting

• Conditions: Opioid-free Anesthesia
• Interventions: Drug: T group

• Registration Number: NCT05577962
• Lead Sponsor: Beijing Friendship Hospital

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.

Detailed Description

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; The routine anesthesia group (Group C) was induced to give sufentanil 0.3-0.5ug/kg, propofol 1-2mg/kg, rocuronium 0.6mg/kg slowly, and then intubated when the anesthetic was fully effective and the BIS value was about 40. Remifentanil was continuously pumped 0.1-0.2ug/kg during operation min； Combined with sevoflurane (MAC 0.8-1) to maintain the depth of anesthesia.

Study Timeline

• Status Verified: 2022-10
• Study First Submitted: 2022-10-07
• Study First Submitted QC: 2022-10-09
• Last Update Submitted: 2022-10-09
• Study First Posted: 2022-10-13
• Last Update Posted: 2022-10-13
• Study Start: 2023-02-01
• Primary Completion: 2023-09-30
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

Not provided

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
T group	T group	Opioid-free Anesthesia

Primary Outcome Measures

Name	Time	Method
The QoR-15 score	Hour 24，Hour 48，Hour 72 after surgery	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).

Secondary Outcome Measures

Name	Time	Method
Incidence of chronic pain and quality of life	3 months after surgery	Incidence of chronic pain and quality of life
Postoperative VAS score	Hour 24，Hour 48，Hour 72 after surgery	Postoperative Visual Analog Scale score, For measurement of the magnitude of pain, the most used scale is "no pain" (corresponding to the scale of 0) and "pain too intense to be tolerated" (corresponding to the scale of 100)
Postoperative fatigue, ICFS scores after surgery	Hour 24，Hour 48，Hour 72 after surgery	Identity-Consequence Fatigue Scale (ICFS) in patients was used to assess the intensity of fatigue.A questionnaire was developed using the 48 items that remained following the content analysis. All items were rated on six-point adjectival scales with anchors from "not at all" to "all of the time" or "not at all" to "more often than usual."
Opioid consumption	Hour 24，Hour 48，Hour 72 after surgery	morphine or equivalent daily consumption after surgery if necesssary
Anesthesia related adverse events	Hour 24，Hour 48，Hour 72 after surgery	Anesthesia related adverse events
Postoperative complication rate	Hour 24，Hour 48，Hour 72 after surgery	Postoperative complication rate
Postoperative mental state	Hour 24，Hour 48，Hour 72 after surgery	Postoperative Mini-Mental State Examination (MMSE) scores.MMSE \<27 was taken to indicate cognitive impairment.

Trial Locations

Locations (1)

Haijun Hou; 🇨🇳 Beijing, China