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CompletedNCT04462094PRO-KetamineUpdated Nov 12, 2020

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

An interventional study of Ketamine 0.3 mg/kg at end-of-surgery and Ketamine 0.3 mg/kg at anesthesia induction in General Anesthesia, Laparotomy and Inflammation, sponsored by Udayana University. Completed at 1 site in Indonesia. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-11-12.

Sponsored by Udayana University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • General Anesthesia
  • Laparotomy
  • Inflammation

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Keywords

  • stress response
  • infammation
  • general anesthesia
03

In context

Inflammation

3,439 studies on the registry are indexed under Inflammation; 629 are open to participants now.

This study's enrollment of 68 is above the median of 50 across 2,437 interventional studies indexed under Inflammation.

Browse Inflammation studies →

Lead sponsor

Udayana University is the lead sponsor of 32 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
68 participants (actual)

Study arms

  • Active comparator
    End-of-surgery

    Low-dose ketamine (0.3 mg/kg) in 3 ml normal saline solution given at the end of surgery

    Drug: Ketamine 0.3 mg/kg at end-of-surgery · Drug: Ketamine 0.3 mg/kg at anesthesia induction

  • Placebo comparator
    Induction

    Low-dose ketamine (0.3 mg/kg) in 3 ml normal saline solution given at induction

    Drug: Ketamine 0.3 mg/kg at end-of-surgery · Drug: Ketamine 0.3 mg/kg at anesthesia induction

Interventions

  • DrugKetamine 0.3 mg/kg at end-of-surgery

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

    Also known as: Group E

  • DrugKetamine 0.3 mg/kg at anesthesia induction

    Ketamine 0.3 mg/kg at anesthesia induction (intravenously)

    Also known as: Group I

06

What researchers measure

Primary outcomes

  1. Serum CRP level

    Serum C-reactive protein level

    Time frame: 1-hour before surgery

  2. Serum CRP level

    Serum C-reactive protein level

    Time frame: 24-hours after surgery

  3. serum neutrophil-count

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

    Time frame: 1-hour before surgery

  4. serum neutrophil-count

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

    Time frame: 24-hours after surgery

  5. VAS (visual analog score)

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

    Time frame: first 24 hours after the surgery

  6. morphine consumption (mg)

    total morphine consumption in 24 hours after the surgery

    Time frame: first 24 hours after the surgery

07

Study locations

1 site
  • Sanglah General Hospital
    Denpasar, Bali 80114, Indonesia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 12, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04462094
Lead sponsor
Udayana University
Responsible party
Christopher Ryalino (Principal Investigator, Udayana University) — Principal investigator
First posted
Jul 8, 2020
Start date
Jul 27, 2020
Primary completion
Sep 30, 2020
Completion
Nov 10, 2020
Last update
Nov 12, 2020

Study contacts

Tjokorda GA Senapathi, Dr
study chair · Udayana University
Christopher Ryalino, Dr
principal investigator · Udayana University
Made SP Adi, Dr
study director · Udayana University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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