General Anesthesia, Inflammation, Laparotomy
Conditions
Keywords
stress response, infammation, general anesthesia
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.
Interventions
DRUGKetamine 0.3 mg/kg at end-of-surgery
Ketamine 0.3 mg/kg at end-of-surgery (intravenously)
DRUGKetamine 0.3 mg/kg at anesthesia induction
Ketamine 0.3 mg/kg at anesthesia induction (intravenously)
Sponsors
Udayana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Only care providers involved directly with the subjects in the operating room are not masked.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum CRP level | 1-hour before surgery | Serum C-reactive protein level |
| serum neutrophil-count | 1-hour before surgery | serum neutrophil-count (from a complete blood count test) |
| VAS (visual analog score) | first 24 hours after the surgery | minimum=0; maximum=10; higher score corresponds to more severe pain |
| morphine consumption (mg) | first 24 hours after the surgery | total morphine consumption in 24 hours after the surgery |
Countries
Indonesia
Outcome results
None listed