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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04462094
Other study ID # UNUD-CTR-FK260620-002
Secondary ID 1143/UN14.2.2.VI
Status Completed
Phase N/A
First received
Last updated
Start date July 27, 2020
Est. completion date November 10, 2020

Study information

Verified date November 2020
Source Udayana University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 68
Est. completion date November 10, 2020
Est. primary completion date September 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Ketamine 0.3 mg/kg at end-of-surgery
Ketamine 0.3 mg/kg at end-of-surgery (intravenously)
Ketamine 0.3 mg/kg at anesthesia induction
Ketamine 0.3 mg/kg at anesthesia induction (intravenously)

Locations

Country Name City State
Indonesia Sanglah General Hospital Denpasar Bali

Sponsors (1)

Lead Sponsor Collaborator
Udayana University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Serum CRP level Serum C-reactive protein level 1-hour before surgery
Primary Serum CRP level Serum C-reactive protein level 24-hours after surgery
Primary serum neutrophil-count serum neutrophil-count (from a complete blood count test) 1-hour before surgery
Primary serum neutrophil-count serum neutrophil-count (from a complete blood count test) 24-hours after surgery
Primary VAS (visual analog score) minimum=0; maximum=10; higher score corresponds to more severe pain first 24 hours after the surgery
Primary morphine consumption (mg) total morphine consumption in 24 hours after the surgery first 24 hours after the surgery
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