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
- Conditions
- LaparotomyGeneral AnesthesiaInflammation
- Interventions
- Registration Number
- NCT04462094
- Lead Sponsor
- Udayana University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 68
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description End-of-surgery Ketamine 0.3 mg/kg at end-of-surgery Low-dose ketamine (0.3 mg/kg) in 3 ml normal saline solution given at the end of surgery Induction Ketamine 0.3 mg/kg at anesthesia induction Low-dose ketamine (0.3 mg/kg) in 3 ml normal saline solution given at induction Induction Ketamine 0.3 mg/kg at end-of-surgery Low-dose ketamine (0.3 mg/kg) in 3 ml normal saline solution given at induction End-of-surgery Ketamine 0.3 mg/kg at anesthesia induction Low-dose ketamine (0.3 mg/kg) in 3 ml normal saline solution given at the end of surgery
- Primary Outcome Measures
Name Time Method serum neutrophil-count 24-hours after surgery serum neutrophil-count (from a complete blood count test)
Serum CRP level 24-hours after surgery Serum C-reactive protein level
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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Sanglah General Hospital
🇮🇩Denpasar, Bali, Indonesia