General AnesthesiaPRO-KetamineNCT04462094
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
A study testing Ketamine 0.3 mg/kg at end-of-surgery and Ketamine 0.3 mg/kg at anesthesia induction in people with General Anesthesia and Laparotomy, run by Udayana University at 1 site in Indonesia.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- General Anesthesia, Laparotomy, Inflammation
- What is being tested?
- Ketamine 0.3 mg/kg at end-of-surgery and Ketamine 0.3 mg/kg at anesthesia induction
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteIndonesia
- Study dates
- 27 Jul 2020to 10 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
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.
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.
- Conditions
- General Anesthesia, Laparotomy, Inflammation
- Being tested
- Ketamine 0.3 mg/kg at end-of-surgery, Ketamine 0.3 mg/kg at anesthesia induction
- Keywords
- stress response, infammation, general anesthesia
- Medical subject headings
- Inflammation, Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine 0.3 mg/kg at end-of-surgeryDrug
Also called Group E
Ketamine 0.3 mg/kg at end-of-surgery (intravenously)
Ketamine 0.3 mg/kg at anesthesia inductionDrug
Also called Group I
Ketamine 0.3 mg/kg at anesthesia induction (intravenously)
| Study group | Role | What they receive |
|---|---|---|
| End-of-surgery | Active comparator | Low-dose ketamine (0.3 mg/kg) in 3 ml normal saline solution given at the end of surgery Receives: 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 Receives: Drug: Ketamine 0.3 mg/kg at end-of-surgery; Drug: Ketamine 0.3 mg/kg at anesthesia induction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum CRP level
Serum C-reactive protein level
Measured: 1-hour before surgery
Serum CRP level
Serum C-reactive protein level
Measured: 24-hours after surgery
serum neutrophil-count
serum neutrophil-count (from a complete blood count test)
Measured: 1-hour before surgery
serum neutrophil-count
serum neutrophil-count (from a complete blood count test)
Measured: 24-hours after surgery
VAS (visual analog score)
minimum=0; maximum=10; higher score corresponds to more severe pain
Measured: first 24 hours after the surgery
morphine consumption (mg)
total morphine consumption in 24 hours after the surgery
Measured: first 24 hours after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start27 Jul 2020
- Primary completion30 Sep 2020
- Study completion10 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Udayana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Ryalino, Udayana University
- Investigators
- Tjokorda GA Senapathi, Dr, Study chair, Udayana UniversityChristopher Ryalino, Dr, Principal investigator, Udayana UniversityMade SP Adi, Dr, Study director, Udayana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04462094
- Sponsor's protocol ID
- UNUD-CTR-FK260620-002
- Other IDs
- 1143/UN14.2.2.VII.14/LT/2020
- Acronym
- PRO-Ketamine
- Status last verified
- Nov 2020
- First submitted
- 26 Jun 2020
- Last updated
- 12 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04462094
- Acronym / sponsor ID
- PRO-Ketamine / UNUD-CTR-FK260620-002
- Conditions
- General Anesthesia, Laparotomy, Inflammation
- Keywords
- stress response, infammation, general anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Udayana UniversityUniversity, hospital or other
- Study start
- 27 Jul 2020 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 10 Nov 2020 (actual)
- First posted
- 8 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| End-of-surgery | Active comparator | Drug: Ketamine 0.3 mg/kg at end-of-surgery, Drug: Ketamine 0.3 mg/kg at anesthesia inductionLow-dose ketamine (0.3 mg/kg) in 3 ml normal saline solution given at the end of surgery |
| Induction | Placebo comparator | Drug: Ketamine 0.3 mg/kg at end-of-surgery, Drug: Ketamine 0.3 mg/kg at anesthesia inductionLow-dose ketamine (0.3 mg/kg) in 3 ml normal saline solution given at induction |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- Contraindication to ketamine.
- Allergy to morphine
- Presence of cardiorespiratory chronic diseases.
- Presence of autoimmune diseases.
- History of the central nervous system or psychiatric disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketamine 0.3 mg/kg at end-of-surgeryAlso: Group EKetamine 0.3 mg/kg at end-of-surgery (intravenously) | Drug | End-of-surgery, Induction |
| Ketamine 0.3 mg/kg at anesthesia inductionAlso: Group IKetamine 0.3 mg/kg at anesthesia induction (intravenously) | Drug | End-of-surgery, Induction |
Primary outcome
Serum CRP level
Time frame: 1-hour before surgery
Serum C-reactive protein level
Serum CRP level
Time frame: 24-hours after surgery
Serum C-reactive protein level
serum neutrophil-count
Time frame: 1-hour before surgery
serum neutrophil-count (from a complete blood count test)
serum neutrophil-count
Time frame: 24-hours after surgery
serum neutrophil-count (from a complete blood count test)
VAS (visual analog score)
Time frame: first 24 hours after the surgery
minimum=0; maximum=10; higher score corresponds to more severe pain
morphine consumption (mg)
Time frame: first 24 hours after the surgery
total morphine consumption in 24 hours after the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tjokorda GA Senapathi, Dr study chair
Udayana University
Christopher Ryalino, Dr principal investigator
Udayana University
Made SP Adi, Dr study director
Udayana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketamine 0.3 mg/kg at end-of-surgery and Ketamine 0.3 mg/kg at anesthesia induction in people with General Anesthesia and Laparotomy, run by Udayana University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum CRP level (time frame: 1-hour before surgery). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2020.