NCT05577962 - Opioid Free Anesthesia on the Quality of Early Recovery | Crick

Overview

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.

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; 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. Total intravenous propofol (BIS guided) plus a continuous remifentanil infusion at 0.1-0.2 μg/kg/min was used to maintain the depth of anesthesia.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

160

Conditions

Opioid-free Anesthesia

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;

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria * 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 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

Locations (1)

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

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).

Time frame: Hour 24 after surgery

Secondary Outcomes

Postoperative VAS score

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)