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Effect of OFA in Laparoscopic Gastrectomy

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
OFA
Control
Sponsored by
Gangnam Severance Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.)

Sites / Locations

  • Gangnam Severance Hospital
  • Gangnam Severance Hsopital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

OFA group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Opioid consumption in postoperative 24hrs
Total opioid dose administered to the patient.

Secondary Outcome Measures

Opioid consumption
Total opioid dose administered to the patient.
Time to bowel function recovery (Gas passing time, Fluid intake start time, Soft diet start time)
Time (hours) to first gas passing / starting oral fluid intake / starting soft diet
Pain score
verbal numerical rating scale 0-10
Nausea score
verbal numerical rating scale 0-10
Time to rescue analgesics after surgery
Time (hours) to first rescue analgesics
Number of vomiting, antiemetic adeministration
Number of vomiting, antiemetic adeministration
Hemodynamics during surgery
changes in hemodyanamics during surgery
QoR-15
Score of QoR-15 questionnaire (Quality of Recovery-15)(Minimum value: 0, Maximum value: 150, higher scores means better.)
PCL-5
Score of PCL-5 (Posttraumatic stress disorder Checklist for DSM-5) (Minimum value: 0, Maximum value: 80, higher scores means worse.)

Full Information

First Posted
September 5, 2021
Last Updated
January 20, 2023
Sponsor
Gangnam Severance Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05076903
Brief Title
Effect of OFA in Laparoscopic Gastrectomy
Official Title
Effect of Opioid Free Anesthesia in Patients Undergoing Laparoscopic Gastrectomy: Subgroup Analysis Based on Psychological Trait
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
September 14, 2021 (Actual)
Primary Completion Date
November 15, 2022 (Actual)
Study Completion Date
November 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gangnam Severance Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Patients don't know which group they belong to.
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OFA group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
OFA
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Opioid consumption in postoperative 24hrs
Description
Total opioid dose administered to the patient.
Time Frame
24 hours after surgery
Secondary Outcome Measure Information:
Title
Opioid consumption
Description
Total opioid dose administered to the patient.
Time Frame
postoperative 6hours, 12hours, 36hours, 48hours, 3days, 4days, 5days
Title
Time to bowel function recovery (Gas passing time, Fluid intake start time, Soft diet start time)
Description
Time (hours) to first gas passing / starting oral fluid intake / starting soft diet
Time Frame
up to 2weeks
Title
Pain score
Description
verbal numerical rating scale 0-10
Time Frame
postoperative 6hours, 12hours, 24hours, 36hours, 48hours, 3days, 4days, 5days, 2weeks
Title
Nausea score
Description
verbal numerical rating scale 0-10
Time Frame
postoperative 6hours, 12hours, 24hours, 36hours, 48hours, 3days, 4days, 5days
Title
Time to rescue analgesics after surgery
Description
Time (hours) to first rescue analgesics
Time Frame
up to 2weeks
Title
Number of vomiting, antiemetic adeministration
Description
Number of vomiting, antiemetic adeministration
Time Frame
up to 2weeks
Title
Hemodynamics during surgery
Description
changes in hemodyanamics during surgery
Time Frame
during surgery
Title
QoR-15
Description
Score of QoR-15 questionnaire (Quality of Recovery-15)(Minimum value: 0, Maximum value: 150, higher scores means better.)
Time Frame
1-5 days before surgery, postoperative 1day, postoperative 4day
Title
PCL-5
Description
Score of PCL-5 (Posttraumatic stress disorder Checklist for DSM-5) (Minimum value: 0, Maximum value: 80, higher scores means worse.)
Time Frame
postoperative 1week
Other Pre-specified Outcome Measures:
Title
Hospital Anxiety Depression Scale
Description
Score of HADS questionnaire (Hospital Anxiety Depression Scale). It consists of 14 items and each item is scored on a scale of 0-3.
Time Frame
1-5 days before surgery
Title
Euro Quality of Life - 5 Dimensions
Description
Score of EQ-5D-5L questionnaire (Five-level version of Euro Quality of Life - 5 Dimensions). It consists of 5 items, and each item is scored on a scale of 1-5.
Time Frame
1-5 days before surgery
Title
Patient Health Questionnaire
Description
Score of PHQ-15 questionnaire (Patient Health Questionnaire-15). It consists of 15 items, and each item is scored on a scale of 0-2.
Time Frame
1-5 days before surgery
Title
Pain Catastrophizing Scale
Description
Score of PCS questionnaire (Pain Catastrophizing Scale). It consists of 13 items, and each item is scored on a scale of 0-4.
Time Frame
1-5 days before surgery
Title
Big Five Inventory-10
Description
Score of BFI-10 questionnaire (Big Five Inventory-10). It consists of 10 items, and each item is scored on a scale of 1-5.
Time Frame
1-5 days before surgery
Title
Hamilton Depression Rating Scale
Description
Score of HAM-D (Hamilton Depression Rating Scale) examination. It consists of 17 items to evalulate depression, and higher scores indicate more severe depression.
Time Frame
1-5 days before surgery
Title
Hamilton Anxiety Rating Scale
Description
Score of HAM-A (Hamilton Anxiety Rating Scale) examination. It consists of 14 items to evalulate anxiety, and higher scores indicate more severe anxiety.
Time Frame
1-5 days before surgery
Title
PainDETECT
Description
Score of PainDETECT questionnaire. It consists of items such as the quality of pain, the pattern of pain, and higher scores indicate more severe neuropathic pain.
Time Frame
1-5 days before surgery
Title
Temporal pain summation
Description
Compare the pain after a single stimulation with the pain after 10 repeated stimulations.
Time Frame
1-5 days before surgery
Title
Pressure pain threshold
Description
The lowest pressure at which the participant perceives pain. It is measured by pressure algometry.
Time Frame
1-5 days before surgery
Title
Pressure pain tolerance
Description
The highest pressure when the participant perceived untolerable pain. It is measured by pressure algometry.
Time Frame
1-5 days before surgery
Title
Frontal Electroencephalogram
Description
Band power and connectivity in electroencephalogram
Time Frame
perioperative period
Title
Analgesia Nociception Index (ANI)
Description
Analgesia Nociception Index (ANI) from ANI monitoring
Time Frame
perioperative period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.)
Facility Information:
Facility Name
Gangnam Severance Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Gangnam Severance Hsopital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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Effect of OFA in Laparoscopic Gastrectomy

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