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

NCT04462094 | Completed

• 2 other identifiers: UNUD-CTR-FK260620-0021143/UN14.2.2.VII.14/LT/2020
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

General Anesthesia; Laparotomy; Inflammation

Keywords

stress response; infammation; general anesthesia

Outcome Measures

Primary Outcomes (6)

• Serum CRP level

  Serum C-reactive protein level

  1-hour before surgery

• Serum CRP level

  Serum C-reactive protein level

  24-hours after surgery

• serum neutrophil-count

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

  1-hour before surgery

• serum neutrophil-count

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

  24-hours after surgery

• VAS (visual analog score)

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

  first 24 hours after the surgery

• morphine consumption (mg)

  total morphine consumption in 24 hours after the surgery

  first 24 hours after the surgery

Study Arms (2)

End-of-surgery

ACTIVE COMPARATOR

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

Induction

PLACEBO COMPARATOR

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

Ketamine 0.3 mg/kg at end-of-surgery DRUG

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

Also known as: Group E

End-of-surgery; Induction

Ketamine 0.3 mg/kg at anesthesia induction DRUG

Ketamine 0.3 mg/kg at anesthesia induction (intravenously)

Also known as: Group I

End-of-surgery; Induction

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Udayana University: lead

Study Sites (1)

Sanglah General Hospital

Denpasar, Bali, 80114, Indonesia

Location

MeSH Terms

Conditions

Inflammation; Fractures, Stress

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fractures, Bone; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Tjokorda GA Senapathi, Dr

  Udayana University

  STUDY CHAIR

• Christopher Ryalino, Dr

  Udayana University

  PRINCIPAL INVESTIGATOR

• Made SP Adi, Dr

  Udayana University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Only care providers involved directly with the subjects in the operating room are not masked.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 26, 2020
• First Posted: July 8, 2020
• Study Start: July 27, 2020
• Primary Completion: September 30, 2020
• Study Completion: November 10, 2020
• Last Updated: November 12, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)