Opioid Free Anesthesia on the Quality of Early Recovery

NCT ID: NCT05577962

Last Updated: 2022-10-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2023-12-31

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.

Conditions

Opioid-free Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

C group

The routine anesthesia group

Group Type: NO_INTERVENTION

No interventions assigned to this group

T group

Opioid-free Anesthesia

Group Type: EXPERIMENTAL

T group

Intervention Type: 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, 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

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Beijing Friendship Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Haijun Hou

Role: PRINCIPAL_INVESTIGATOR

Beijing Friendship Hospital

Locations

Haijun Hou

Beijing, , China

Countries

China

Central Contacts

Haijun Hou

Role: CONTACT

lumen208@foxmail.com

+8618612568228

lu liu

Role: CONTACT

emmaliulu@163.com

+8618618418228

Other Identifiers

opioid-free anesthesia

Identifier Type: -

Identifier Source: org_study_id