Health TrialsbyHealthPanel

Opioid Free Anesthesia on the Quality of Early Recovery

ConditionOpioid-free Anesthesia
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-99
SponsorBeijing Friendship Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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;

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: C groupNo intervention 0 interventions
Group B: T groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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)

Time frame
Hour 24，Hour 48，Hour 72 after surgery
2

Postoperative complication rate

Postoperative complication rate

Time frame
Hour 24，Hour 48，Hour 72 after surgery
3

Opioid consumption

morphine or equivalent daily consumption after surgery if necesssary

Time frame
Hour 24，Hour 48，Hour 72 after surgery
4

Anesthesia related adverse events

Anesthesia related adverse events

Time frame
Hour 24，Hour 48，Hour 72 after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Friendship Hospital

Lead sponsor

Source ClinicalTrials.gov
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