Multimodal Analgesic Management of Naborphine Combined With Opioid Free Anesthesia in OSA Patients Undergoing Bariatric Surgery

Multimodal Analgesic Management of Naborphine Combined With Opioid Free Under General Anesthesia in OSA Patients Undergoing Weight Loss Surgery Under the Concept of ERAS: a Prospective, Randomized, Parallel Controlled Study

Comparative study to explore the effect of opioid free anesthesia technology in perioperative analgesia management, clarify the effect of naborphine instead of opioids on perioperative analgesia management in morbid obesity patients with moderate and severe OSA, reduce related adverse events, and explore the latest clinical anesthetic drugs.

Study Overview

• Status: Not yet recruiting
• Conditions: Analgesics，Opioid; Bariatric Surgery
• Intervention / Treatment: Procedure: Opioid free anesthesia technology

Detailed Description

1. The concept of enhanced recovery after surgery (ERAS) has been applied in the perioperative period of many operations. Reducing the dosage of opioids is an important part of the concept of ERAS.
2. Opioid free anesthesia technology has been recognized in reducing nausea and vomiting, but whether it can meet the perioperative analgesic needs of patients undergoing bariatric surgery and obtain more clinical benefits still has no research supportment.
3. This study is expected to clarify the clinical effect of opioid free anesthesia technology in perioperative analgesia management of morbid obesity patients with moderate and severe OSA, reduce adverse events, and explore the latest clinical anesthesia scheme.

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250000
      • Yongtao Sun

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. ASA grade I ~ III;
2. Age from 18 - 65 years old;
3. BMI ≥ 35kg / m2 in patients with OSA to undergo bariatric surgery； （4 provide written informed consent for participation.

Exclusion Criteria:

1. Age < 18 years or age >65 years old;
2. Pregnancy test was positive;
3. Patients with a history of drug abuse or dependence on opioids;
4. Patients with chronic pain or severe heart, lung, liver or nervous system diseases

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Opioid anesthesia group; Anesthesia induction with propofol 2.5mg/kg, rocuronium bromide 0.6mg/kg, sufentanil 0.3μg/kg, intubation was performed when BIS value reached 40-60. Intraoperative pump injection of propofol 4-12 mg/kg·h and remifentanil 0.2-0.5 μg/kg·min to maintain anesthesia. Ultrasound-guided transversus abdominis plane block (with 0.375% ropivacaine 40ml) will be implemented preoperatively. Ondansetron 8mg and sufentanil 10 μg will be given after surgery. For PCA, sufentanil 2μg/kg + dexmedetomidine 2μg/kg + ondansetron 24mg.	Procedure: Opioid free anesthesia technology; We have adopted a variety of methods to replace the use of opioids in the process of balanced anesthesia.
Experimental: Opioid free anesthesia group; Anesthesia induction with propofol 2.5mg/kg, rocuronium bromide 0.6mg/kg, naborphine 0.2mg/kg，esketamine 0.3mg/kg, intubation was performed when BIS value reached 40-60. Intraoperative pump injection of propofol 4-12 mg/kg·h and esketamine 0.3～0.5mg/kg·h. Ultrasound-guided transversus abdominis plane block (with 0.375% ropivacaine 40ml) will be implemented preoperatively. Ondansetron 8mg and naborphine 0.2mg/kg will be given after surgery. For PCA, naborphine 2mg/kg + dexmedetomidine 2μg/kg + ondansetron 24mg.	Procedure: Opioid free anesthesia technology; We have adopted a variety of methods to replace the use of opioids in the process of balanced anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative NRS score	A subjective psychometric response scale used to measure distinct behavioral or physiological phenomena based on linear numerical gradient or yes/no alternatives. The Numeric Pain Scale (NRS) pain numerical score(0-10 score, 0: no pain, 10: worst imaginable pain). A pain measurement list about quiet NRS score and cough NRS score at different postoperative time will be used.	Score from the end of the operation and follow-up at the time point specified in the scoring form for a total of 27 hours.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dosage of remedial analgesics postoperatively	If the participant still feels severe pain after operation and needs additional analgesic drugs for treatment, we will record the type and dose of drugs used by the patient.	It takes about 24 hours.
Hemodynamic fluctuation	Hemodynamic fluctuation during perioperative period. The levels of SBP in mmHg, DBP in mmHg, MAP in mmHg and HR in times/minute in basic(T0), after induction(T1), preoperative(T2) and after establishing pneumoperitoneum(T3) 1h after the pneumoperitoneum(T4) and Immediately after operation(T5), Before(T6) and after(T7) extubation were recorded.	From the beginning of the general anesthesia induction to the time leaving PACU, it takes about 4 hours.
Ramsay scale	Ramsay scale is the most widely used sedation scoring standard in clinic, which is simple and practical. This scale has multiple advantages: it is reproducible, easily executed and has good applicability. This has made the scale the most widely used to assess level of sedation for procedures in pediatrics. It is divided into six levels(1-6): 1 shows patient is anxious and agitated or restless, or both; 2 shows patient is co-operative, oriented, and tranquil; 3 shows patient responds to commands only; 4 shows patient exhibits brisk response to light tactile stimuli or loudauditory stimulus; 5 shows patient exhibits sluggish response to light tactile stimuli or loud auditory stimulus; 6 shows patient exhibits no response.	Score from the end of the operation and follow-up at the time point specified in the scoring form for a total of 27 hours.
recovery time	From the time when the patient entered PACU to the time when the participant meets the standard of leaving the PACU.	It will take up to 1 hour or 2 hours.
The levels of C-reactive protein (CRP)	We will collect the participant's blood at the time before surgery(T0), after surgery(T1), and 24h after surgery(T2) to obtain the levels of C-reactive protein (mg/L).	It takes about 24 hours.
The levels of cortisol (COR).	We will collect the participant's blood at the time before surgery(T0), after surgery(T1), and 24h after surgery(T2) to obtain the levels of cortisol (nmol/L).	It takes about 24 hours.
The levels of blood glucose (BG)	We will collect the participant's blood at the time before surgery(T0), after surgery(T1), and 24h after surgery(T2) to obtain the levels of blood glucose (mmol/L).	It takes about 24 hours.
The levels of interleukin-6 (IL-6).	We will collect the participant's blood at the time before surgery(T0), after surgery(T1), and 24h after surgery(T2) to obtain the levels of IL-6 (pg/mL).	It takes about 24 hours.
Scores of 15-item Quality of Recovery (QoR-15) scale 24 hours postoperatively of participants.	The QoR-15 scale is a validated tool to assess the quality of postoperative recovery (QoR) from 0 to 150. The QoR was classified as excellent (QoR-15 > 135), good (122 ≤ QoR-15 ≤ 135), moderate (90 ≤ QoR-15 ≤ 121) or poor (QoR-15 < 90).	One day after the surgery.
Rate of postoperative nausea and vomiting	Postoperative nausea and vomiting will be recorded if it happens.	It takes about 24 hours.
Acceptability of participants with laryngeal mask 24 hours after surgery.	One day after surgery, we will record the acceptability of laryngeal mask and the degree of postoperative pharyngeal pain of the participants. Acceptability of participants with laryngeal mask will be assessed by whether the participant was willing to receive laryngeal mask anesthesia again. Pharyngeal pain can be evaluated using the Numeric Pain Scale (NRS) pain numerical score. A subjective psychometric response scale used to measure distinct behavioral or physiological phenomena based on linear numerical gradient or yes/no alternatives. The Numeric Pain Scale (NRS) pain numerical score(0-10 score, 0: no pain, 10: worst imaginable pain).	One day after the surgery.

Collaborators and Investigators

• Sponsor: Qianfoshan Hospital
• Investigators: Principal Investigator: Yongtao Sun, doctor, Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): May 15, 2022
• Primary Completion (Anticipated): January 31, 2023
• Study Completion (Anticipated): October 31, 2023

Study Registration Dates

• First Submitted: May 10, 2022
• First Submitted That Met QC Criteria: May 22, 2022
• First Posted (Actual): May 24, 2022

Study Record Updates

• Last Update Posted (Actual): May 24, 2022
• Last Update Submitted That Met QC Criteria: May 22, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Bariatric Surgery; ERAS; Opioid free anesthesia
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Narcotics; Anesthetics; Analgesics, Opioid
• Other Study ID Numbers: YXLL-KY-2022(035)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No