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.
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
48
We have adopted a variety of methods to replace the use of opioids in the process of balanced anesthesia.
Yongtao Sun
Jinan, Shandong, China
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.
Time frame: 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.
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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: One day after the surgery.
Rate of postoperative nausea and vomiting
Postoperative nausea and vomiting will be recorded if it happens.
Time frame: 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).
Time frame: One day after the surgery.