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Comparison of CRP Levels, Neutrophil Count, and Clinical Outcomes of Low Dose Ketamine Between at Anesthesia Induction and at the End of Surgery in Patients Undergo Elective Laparotomy (PRO-Ketamine)

Primary Purpose

General Anesthesia, Laparotomy, Inflammation

Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Ketamine 0.3 mg/kg at end-of-surgery
Ketamine 0.3 mg/kg at anesthesia induction
Sponsored by
Udayana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for General Anesthesia focused on measuring stress response, infammation, general anesthesia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients undergoing elective laparotomy with general anesthesia at Sanglah Hospital from July to September 2020.
  2. Patients aged 18-65 years.
  3. Patient physical status American American Society of Anesthesiologist (ASA) 1 and 2.

Exclusion Criteria:

  1. Contraindication to ketamine.
  2. Allergy to morphine
  3. Presence of cardiorespiratory chronic diseases.
  4. Presence of autoimmune diseases.
  5. History of the central nervous system or psychiatric disorders.
  6. BMI <18.5 kg/m2 or ≥30 kg/m2.
  7. A history of chronic pain killer medications (such as opioid or non-steroidal anti- inflammatory drugs)

Drop Out Criteria

  1. Patients with class 3 bleeding during the surgery
  2. Patients with more than 5-hours duration of surgery
  3. Patients need mechanical ventilation after the surgery

Sites / Locations

  • Sanglah General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

End-of-surgery

Induction

Arm Description

Low-dose ketamine (0.3 mg/kg) in 3 ml normal saline solution given at the end of surgery

Low-dose ketamine (0.3 mg/kg) in 3 ml normal saline solution given at induction

Outcomes

Primary Outcome Measures

Serum CRP level
Serum C-reactive protein level
Serum CRP level
Serum C-reactive protein level
serum neutrophil-count
serum neutrophil-count (from a complete blood count test)
serum neutrophil-count
serum neutrophil-count (from a complete blood count test)
VAS (visual analog score)
minimum=0; maximum=10; higher score corresponds to more severe pain
morphine consumption (mg)
total morphine consumption in 24 hours after the surgery

Secondary Outcome Measures

Full Information

First Posted
June 26, 2020
Last Updated
November 9, 2020
Sponsor
Udayana University
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1. Study Identification

Unique Protocol Identification Number
NCT04462094
Brief Title
Comparison of CRP Levels, Neutrophil Count, and Clinical Outcomes of Low Dose Ketamine Between at Anesthesia Induction and at the End of Surgery in Patients Undergo Elective Laparotomy
Acronym
PRO-Ketamine
Official Title
Comparison of CRP Levels, Neutrophil Count, and Clinical Outcomes of Low Dose Ketamine Between at Anesthesia Induction and at the End of Surgery in Patients Undergo Elective Laparotomy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
July 27, 2020 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
November 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Udayana University

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 effects of anesthesia and surgery can lead to stress responses that result in hormonal and metabolic changes in the body. The immune system and the nervous system communicate both ways, and it was found that nociception and proinflammatory cytokines play a joint regulatory role, i.e., increased production of proinflammatory cytokines can worsen the pain. Major surgery can trigger the release of cytokines such as IL-1, IL-6, and TNF-α.
Detailed Description
The effects of anesthesia and surgery can lead to stress responses that result in hormonal and metabolic changes in the body. The immune system and the nervous system communicate both ways, and it was found that nociception and proinflammatory cytokines play a joint regulatory role, i.e., increased production of proinflammatory cytokines can worsen the pain. Major surgery can trigger the release of cytokines such as IL-1, IL-6, and TNF-α. The acute analgesic effect of ketamine is generally believed to be mediated through the blockade of the phencyclidine binding site of the N-methyl-d-aspartate (NMDA) receptor of nociceptive neurons. Ketamine can reduce the inflammatory response marked by a decrease in CRP levels to surgical trauma and can prevent secondary damage to tissues/organs that were not initially affected by surgery by reducing inflammation. This also reduces postoperative pain and analgesics.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
General Anesthesia, Laparotomy, Inflammation
Keywords
stress response, infammation, general anesthesia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a double-blind, randomized control trial. It provides a controlled care comparison between low-dose ketamine given at anesthesia induction and at the end-of-surgery.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Only care providers involved directly with the subjects in the operating room are not masked.
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
End-of-surgery
Arm Type
Active Comparator
Arm Description
Low-dose ketamine (0.3 mg/kg) in 3 ml normal saline solution given at the end of surgery
Arm Title
Induction
Arm Type
Placebo Comparator
Arm Description
Low-dose ketamine (0.3 mg/kg) in 3 ml normal saline solution given at induction
Intervention Type
Drug
Intervention Name(s)
Ketamine 0.3 mg/kg at end-of-surgery
Other Intervention Name(s)
Group E
Intervention Description
Ketamine 0.3 mg/kg at end-of-surgery (intravenously)
Intervention Type
Drug
Intervention Name(s)
Ketamine 0.3 mg/kg at anesthesia induction
Other Intervention Name(s)
Group I
Intervention Description
Ketamine 0.3 mg/kg at anesthesia induction (intravenously)
Primary Outcome Measure Information:
Title
Serum CRP level
Description
Serum C-reactive protein level
Time Frame
1-hour before surgery
Title
Serum CRP level
Description
Serum C-reactive protein level
Time Frame
24-hours after surgery
Title
serum neutrophil-count
Description
serum neutrophil-count (from a complete blood count test)
Time Frame
1-hour before surgery
Title
serum neutrophil-count
Description
serum neutrophil-count (from a complete blood count test)
Time Frame
24-hours after surgery
Title
VAS (visual analog score)
Description
minimum=0; maximum=10; higher score corresponds to more severe pain
Time Frame
first 24 hours after the surgery
Title
morphine consumption (mg)
Description
total morphine consumption in 24 hours after the surgery
Time Frame
first 24 hours after the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients undergoing elective laparotomy with general anesthesia at Sanglah Hospital from July to September 2020. Patients aged 18-65 years. Patient physical status American American Society of Anesthesiologist (ASA) 1 and 2. Exclusion Criteria: Contraindication to ketamine. Allergy to morphine Presence of cardiorespiratory chronic diseases. Presence of autoimmune diseases. History of the central nervous system or psychiatric disorders. BMI <18.5 kg/m2 or ≥30 kg/m2. A history of chronic pain killer medications (such as opioid or non-steroidal anti- inflammatory drugs) Drop Out Criteria Patients with class 3 bleeding during the surgery Patients with more than 5-hours duration of surgery Patients need mechanical ventilation after the surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tjokorda GA Senapathi, Dr
Organizational Affiliation
Udayana University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Christopher Ryalino, Dr
Organizational Affiliation
Udayana University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Made SP Adi, Dr
Organizational Affiliation
Udayana University
Official's Role
Study Director
Facility Information:
Facility Name
Sanglah General Hospital
City
Denpasar
State/Province
Bali
ZIP/Postal Code
80114
Country
Indonesia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparison of CRP Levels, Neutrophil Count, and Clinical Outcomes of Low Dose Ketamine Between at Anesthesia Induction and at the End of Surgery in Patients Undergo Elective Laparotomy

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