NCT05577962

Opioid Free Anesthesia on the Quality of Early Recovery

The Effect of Opioid-free Anesthesia Protocol on the Early Quality of Recovery After Thyroidectomy (TOFA Trial): Study Protocol for a Prospective, Monocentric, Randomized, Single-blinded Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Beijing Friendship Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

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.

Conditions

• Opioid-free Anesthesia

Interventions

Type	Name	Description
DRUG	T group	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

Timeline

• Start date: 2023-02-01
• Primary completion: 2023-09-30
• Completion: 2023-12-31
• First posted: 2022-10-13
• Last updated: 2022-10-13

Locations

1 site across 1 country: China