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

Inflammation Clinical Trial

— PRO-Ketamine  

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

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
• 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
• 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

Related Conditions & MeSH terms

• General Anesthesia
• Inflammation
• Laparotomy

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