Serum C-reactive protein level
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
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.
Intervention / Treatment
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.
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Ketamine 0.3 mg/kg at end-of-surgery (DRUG)Ketamine 0.3 mg/kg at end-of-surgery (intravenously)
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Ketamine 0.3 mg/kg at anesthesia induction (DRUG)Ketamine 0.3 mg/kg at anesthesia induction (intravenously)
Condition or Disease
- General Anesthesia
- Laparotomy
- Inflammation
Phase
Study Design
| Study type: | INTERVENTIONAL |
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| Status: | Completed |
| Study results: | No Results Available |
| Age: | 18 Years to 65 Years |
| Enrollment: | 68 (ACTUAL) |
| Funded by: | Other |
| Allocation: | Randomized |
| Primary Purpose: | Supportive Care |
MaskingOnly care providers involved directly with the subjects in the operating room are not masked. TRIPLE:
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Clinical Trial Dates
| Start date: | Jul 27, 2020 | ACTUAL |
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| Primary Completion: | Sep 30, 2020 | ACTUAL |
| Completion Date: | Nov 10, 2020 | ACTUAL |
| Study First Posted: | Jul 08, 2020 | ACTUAL |
| Results First Posted: | Aug 31, 2020 | |
| Last Updated: | Nov 09, 2020 |
Sponsors / Collaborators
Lead Sponsor:
Udayana University
Responsible Party:
N/A
Location
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.
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.
Participant Groups
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Low-dose ketamine (0.3 mg/kg) in 3 ml normal saline solution given at the end of surgery
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Low-dose ketamine (0.3 mg/kg) in 3 ml normal saline solution given at induction
Eligibility Criteria
| Sex: | All |
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| Minimum Age: | 18 |
| Maximum Age: | 65 |
| Age Groups: | Adult / Older Adult |
| Healthy Volunteers: | Yes |
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
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
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Serum C-reactive protein level
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serum neutrophil-count (from a complete blood count test)
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serum neutrophil-count (from a complete blood count test)
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minimum=0; maximum=10; higher score corresponds to more severe pain
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total morphine consumption in 24 hours after the surgery
More Details
| NCT Number: | NCT04462094 |
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| Acronym: | PRO-Ketamine |
| Other IDs: | UNUD-CTR-FK260620-002 |
| Study URL: | https://clinicaltrials.gov/study/NCT04462094 |
Last updated: Sep 29, 2023