Effect of OFA in Laparoscopic Gastrectomy

NCT05076903 | Completed

• 1 other identifier: 3-2021-0295
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Opioid consumption in postoperative 24hrs

  Total opioid dose administered to the patient.

  24 hours after surgery

Secondary Outcomes (9)

• Opioid consumption

  postoperative 6hours, 12hours, 36hours, 48hours, 3days, 4days, 5days

• Time to bowel function recovery (Gas passing time, Fluid intake start time, Soft diet start time)

  up to 2weeks

• Pain score

  postoperative 6hours, 12hours, 24hours, 36hours, 48hours, 3days, 4days, 5days, 2weeks

• Nausea score

  postoperative 6hours, 12hours, 24hours, 36hours, 48hours, 3days, 4days, 5days

• Time to rescue analgesics after surgery

  up to 2weeks

Other Outcomes (13)

• Hospital Anxiety Depression Scale

  1-5 days before surgery

• Euro Quality of Life - 5 Dimensions

  1-5 days before surgery

• Patient Health Questionnaire

  1-5 days before surgery

Study Arms (2)

OFA group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

OFA DRUG

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.

OFA group

Control DRUG

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.

Control group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 19 years who underwent laparoscopic gastrectomy for gastric cancer

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Gangnam Severance Hospital: lead

Study Sites (2)

Gangnam Severance Hospital

Seoul, South Korea

Location

Gangnam Severance Hsopital

Seoul, South Korea

Location

Related Publications (1)

• Bae MI, Oh J, Lee HS, Park S, Kwon IG, Song Y. Influence of psychological factors and pain sensitivity on the efficacy of opioid-free anesthesia: A randomized clinical trial. Gen Hosp Psychiatry. 2024 Jul-Aug;89:84-92. doi: 10.1016/j.genhosppsych.2024.04.001. Epub 2024 Apr 4.

  PMID: 38838608 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients don't know which group they belong to.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 5, 2021
• First Posted: October 13, 2021
• Study Start: September 14, 2021
• Primary Completion: November 15, 2022
• Study Completion: November 15, 2022
• Last Updated: January 23, 2023

Record last verified: 2023-01

Locations

KR (2)