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Completed

NCT Number: 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

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.

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Key information

Conditions

General Anesthesia Fractures, Bone Fractures, Stress Inflammation Laparotomy Pathologic Processes Pathological Conditions, Signs and Symptoms Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sanglah General Hospital

Denpasar, Bali, 80114, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Ketamine 0.3 mg/kg at end-of-surgery

Drug

Ketamine 0.3 mg/kg at end-of-surgery (intravenously)

Other names: Group E

Ketamine 0.3 mg/kg at anesthesia induction

Drug

Ketamine 0.3 mg/kg at anesthesia induction (intravenously)

Other names: Group I

Primary outcomes

  1. Serum CRP level

    Time frame: 1-hour before surgery

    Serum C-reactive protein level

  2. Serum CRP level

    Time frame: 24-hours after surgery

    Serum C-reactive protein level

  3. serum neutrophil-count

    Time frame: 1-hour before surgery

    serum neutrophil-count (from a complete blood count test)

  4. serum neutrophil-count

    Time frame: 24-hours after surgery

    serum neutrophil-count (from a complete blood count test)

  5. VAS (visual analog score)

    Time frame: first 24 hours after the surgery

    minimum=0; maximum=10; higher score corresponds to more severe pain

  6. morphine consumption (mg)

    Time frame: first 24 hours after the surgery

    total morphine consumption in 24 hours after the surgery

Sponsors and collaborators

Lead sponsor

Udayana University

Other

Registry information

Acronym: PRO-Ketamine

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 8, 2020
Registry last updated
Nov 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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