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Clinical Trials/NCT04462094
NCT04462094
Completed
Not Applicable

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

Udayana University1 site in 1 country68 target enrollmentJuly 27, 2020

Overview

Phase
Not Applicable
Intervention
Ketamine 0.3 mg/kg at end-of-surgery
Conditions
General Anesthesia
Sponsor
Udayana University
Enrollment
68
Locations
1
Primary Endpoint
serum neutrophil-count
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 27, 2020
End Date
November 10, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Udayana University
Responsible Party
Principal Investigator
Principal Investigator

Christopher Ryalino

Principal Investigator

Udayana University

Eligibility Criteria

Inclusion Criteria

  • Patients undergoing elective laparotomy with general anesthesia at Sanglah Hospital from July to September
  • 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/m
  • 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

Arms & Interventions

End-of-surgery

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

Intervention: Ketamine 0.3 mg/kg at end-of-surgery

End-of-surgery

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

Intervention: Ketamine 0.3 mg/kg at anesthesia induction

Induction

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

Intervention: Ketamine 0.3 mg/kg at end-of-surgery

Induction

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

Intervention: Ketamine 0.3 mg/kg at anesthesia induction

Outcomes

Primary Outcomes

serum neutrophil-count

Time Frame: 24-hours after surgery

serum neutrophil-count (from a complete blood count test)

Serum CRP level

Time Frame: 24-hours after surgery

Serum C-reactive protein level

VAS (visual analog score)

Time Frame: first 24 hours after the surgery

minimum=0; maximum=10; higher score corresponds to more severe pain

morphine consumption (mg)

Time Frame: first 24 hours after the surgery

total morphine consumption in 24 hours after the surgery

Study Sites (1)

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