Effect of OFA in Laparoscopic Gastrectomy

Sponsor

Gangnam Severance Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05076903

Collaborator

(none)

120

Enrollment

Locations

Arms

23.6

Anticipated Duration (Months)

Patients Per Site

2.5

Patients Per Site Per Month

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 Disease	Intervention/Treatment	Phase
Postoperative Pain	Drug: OFA Drug: Control	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

Actual Study Start Date :

Sep 14, 2021

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

Arm	Intervention/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.

Arm

Intervention/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

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

Outcome Measures

Primary Outcome Measures

Opioid consumption in postoperative 24hrs [24 hours after surgery]
Total opioid dose administered to the patient.

Secondary Outcome Measures

Opioid consumption [postoperative 6hours, 12hours, 36hours, 48hours, 3days, 4days, 5days]
Total opioid dose administered to the patient.
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
Pain score [postoperative 6hours, 12hours, 24hours, 36hours, 48hours, 3days, 4days, 5days, 2weeks]
verbal numerical rating scale 0-10
Nausea score [postoperative 6hours, 12hours, 24hours, 36hours, 48hours, 3days, 4days, 5days]
verbal numerical rating scale 0-10
Time to rescue analgesics after surgery [up to 2weeks]
Time (hours) to first rescue analgesics
Number of vomiting, antiemetic adeministration [up to 2weeks]
Number of vomiting, antiemetic adeministration
Hemodynamics during surgery [during surgery]
changes in hemodyanamics during surgery
QoR-15 [postoperative 1day, 4day]
Score of QoR-15 questionnaire (Quality of Recovery-15)(Minimum value: 0, Maximum value: 150, higher scores means better.)
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:

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

	Site	City	State	Country	Postal Code
1	Gangnam Severance Hospital	Seoul		Korea, Republic of
2	Gangnam Severance Hsopital	Seoul		Korea, Republic of

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:

Mar 23, 2022

Last Verified:

Mar 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pain, Postoperative

Study Results

No Results Posted as of Mar 23, 2022