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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

NCT ID: NCT04462094

Last Updated: 2020-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-27

Study Completion Date

2020-11-10

Brief Summary

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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.

Detailed Description

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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.

Conditions

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General Anesthesia Laparotomy Inflammation

Keywords

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stress response infammation general anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Only care providers involved directly with the subjects in the operating room are not masked.

Study Groups

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End-of-surgery

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

Group Type ACTIVE_COMPARATOR

Ketamine 0.3 mg/kg at end-of-surgery

Intervention Type DRUG

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

Ketamine 0.3 mg/kg at anesthesia induction

Intervention Type DRUG

Ketamine 0.3 mg/kg at anesthesia induction (intravenously)

Induction

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

Group Type PLACEBO_COMPARATOR

Ketamine 0.3 mg/kg at end-of-surgery

Intervention Type DRUG

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

Ketamine 0.3 mg/kg at anesthesia induction

Intervention Type DRUG

Ketamine 0.3 mg/kg at anesthesia induction (intravenously)

Interventions

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Ketamine 0.3 mg/kg at end-of-surgery

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

Intervention Type DRUG

Ketamine 0.3 mg/kg at anesthesia induction

Ketamine 0.3 mg/kg at anesthesia induction (intravenously)

Intervention Type DRUG

Other Intervention Names

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Group E Group I

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Udayana University

OTHER

Sponsor Role lead

Responsible Party

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Christopher Ryalino

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tjokorda GA Senapathi, Dr

Role: STUDY_CHAIR

Udayana University

Christopher Ryalino, Dr

Role: PRINCIPAL_INVESTIGATOR

Udayana University

Made SP Adi, Dr

Role: STUDY_DIRECTOR

Udayana University

Locations

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Sanglah General Hospital

Denpasar, Bali, Indonesia

Site Status

Countries

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Indonesia

Other Identifiers

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1143/UN14.2.2.VII.14/LT/2020

Identifier Type: OTHER

Identifier Source: secondary_id

UNUD-CTR-FK260620-002

Identifier Type: -

Identifier Source: org_study_id