Effect of OFA in Laparoscopic Gastrectomy

Sponsor
Gangnam Severance Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05076903
Collaborator
(none)
120
Enrollment
2
Arms
22.4
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The investigator will examine the effects of opioid free anesthesia in patients undergoing laparoscopic gastrectomy. The investigator expect that opioid free anesthesia will reduce postoperative pain and opioid consumption.

And investigator will analyze the association between postoperative pain and patient's underlying psychological characteristics and pain sensitivity. The investigator anticipate that psychological characteristics and pain sensitivity may be realted to postoperative pain and opioid consumption.

Condition or DiseaseIntervention/TreatmentPhase
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Masking Description:
Patients don't know which group they belong to.
Primary Purpose:
Prevention
Official Title:
Effect of Opioid Free Anesthesia in Patients Undergoing Laparoscopic Gastrectomy: Subgroup Analysis Based on Psychological Trait
Anticipated Study Start Date :
Oct 20, 2021
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

ArmIntervention/Treatment
Experimental: OFA group

Dexmedetomidine and lidocaine are administered during anesthesia, and opioid is not used. For induction, 1 μg/kg of Dexmedetomidine is administered over 10 minutes and 1mg/kg of lidocaine is administered intavenously (bolus). This is followed by continuous intravenous infusion of dexmedetomidine at a rate of 0.2-0.7 μg/kg/h and infusion of lidocaine at the rate of 1 mg/kg/h.

Drug: OFA
Dexmedetomidine and lidocaine are administered during anesthesia, and opioid is not used. For induction, 1 μg/kg of Dexmedetomidine is administered over 10 minutes and 1mg/kg of lidocaine is administered intavenously (bolus). This is followed by continuous intravenous infusion of dexmedetomidine at a rate of 0.2-0.7 μg/kg/h and infusion of lidocaine at the rate of 1 mg/kg/h.

Active Comparator: Control group

Remifentanil is infused during anesthesia, and target-controlled infusion (TCI) is performed according to the Minto model. During indcution of anestheisa, target concentration of remifentanil is set within 3-5 ng/mL. After intubation, target concentration is adjusted within the range of 2-8 ng/mL.

Drug: Control
Remifentanil is infused during anesthesia, and target-controlled infusion (TCI) is performed according to the Minto model. During indcution of anestheisa, target concentration of remifentanil is set within 3-5 ng/mL. After intubation, target concentration is adjusted within the range of 2-8 ng/mL.

Outcome Measures

Primary Outcome Measures

  1. Opioid consumption in postoperative 24hrs [24 hours after surgery]

    Total opioid dose administered to the patient.

Secondary Outcome Measures

  1. Opioid consumption [postoperative 6hours, 12hours, 36hours, 48hours, 3days, 4days, 5days]

    Total opioid dose administered to the patient.

  2. Time to bowel function recovery (Gas passing time, Fluid intake start time, Soft diet start time) [up to 2weeks]

    Time (hours) to first gas passing / starting oral fluid intake / starting soft diet

  3. Pain score [postoperative 6hours, 12hours, 24hours, 36hours, 48hours, 3days, 4days, 5days, 2weeks]

    verbal numerical rating scale 0-10

  4. Nausea score [postoperative 6hours, 12hours, 24hours, 36hours, 48hours, 3days, 4days, 5days]

    verbal numerical rating scale 0-10

  5. Time to rescue analgesics after surgery [up to 2weeks]

    Time (hours) to first rescue analgesics

  6. Number of vomiting, antiemetic adeministration [up to 2weeks]

    Number of vomiting, antiemetic adeministration

  7. Hemodynamics during surgery [during surgery]

    changes in hemodyanamics during surgery

  8. QoR-15 [postoperative 1day, 4day]

    Score of QoR-15 questionnaire (Quality of Recovery-15)(Minimum value: 0, Maximum value: 150, higher scores means better.)

  9. PCL-5 [postoperative 1week]

    Score of PCL-5 (Posttraumatic stress disorder Checklist for DSM-5) (Minimum value: 0, Maximum value: 80, higher scores means worse.)

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients over 19 years who underwent laparoscopic gastrectomy for gastric cancer
Exclusion Criteria:
  • Patients with a history of allergic reactions to drugs

  • Patients with a history of drug addiction

  • Patients with chronic pain who require analgesics

  • Patients with cancer other than the stomach

  • History of hospitalization for psychiatric disorders

  • Patients with sleep apnea

  • Preoperative pulse oximetry (SpO2) < 95 %

  • Moderate or severe hepatic impairment

  • bradycardia (HR<50bpm), hypotension, atrioventricular block, intraventricular or sinus block

  • Body mass index over 35 kg/m2

  • Blood clotting disorders

  • Pregnant/lactating women

  • Cognitive impairment

  • Unable to read consent form (eg illiterate, foreigner, etc.)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Gangnam Severance Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Young Song, Professor, Gangnam Severance Hospital
ClinicalTrials.gov Identifier:
NCT05076903
Other Study ID Numbers:
  • 3-2021-0295
First Posted:
Oct 13, 2021
Last Update Posted:
Oct 13, 2021
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 13, 2021