Clinical trial NCT04462094: 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
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
Overall status: COMPLETED
Phase: NA
Conditions: General Anesthesia
Laparotomy
Inflammation
Keywords: stress response
infammation
general anesthesia
Lead sponsor: Udayana University
Sponsor class: OTHER
First posted: 2020-07-08
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Serum CRP level
timeFrame: 1-hour before surgery
measure: Serum CRP level
timeFrame: 24-hours after surgery
measure: serum neutrophil-count
timeFrame: 1-hour before surgery
measure: serum neutrophil-count
timeFrame: 24-hours after surgery
measure: VAS (visual analog score)
timeFrame: first 24 hours after the surgery
measure: morphine consumption (mg)
timeFrame: first 24 hours after the surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Denpasar
country: Indonesia
facility: Sanglah General Hospital
state: Bali
Study officials:
affiliation: Udayana University
name: Tjokorda GA Senapathi, Dr
role: STUDY_CHAIR
affiliation: Udayana University
name: Christopher Ryalino, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Udayana University
name: Made SP Adi, Dr
role: STUDY_DIRECTOR
References: