CholelithiasisNCT05444777
The Effect of Low Dose Ketamine on Narcotic Consumption in Patients Undergoing Laparoscopic Cholecystectomy
A study testing Ketamine Hydrochloride in people with Cholelithiasis, run by Aga Khan University.
Trial summary
This double-blinded randomized control trial aims to analyze the effect of low dose Ketamine on narcotic consumption, in patients undergoing Laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cholelithiasis
- What is being tested?
- Ketamine Hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- No sites listed yet
- Study dates
- 17 Jan 2013to 30 Nov 2013
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- all ASA 1 and 2 patients undergoing Laparoscopic Cholecystectomy electively.
Who cannot join
- Hepatic and renal disease and ASA 3 and 4 patients.
About this study
This double-blinded randomized control trial aims to analyze the effect of low dose Ketamine on narcotic consumption, in patients undergoing Laparoscopic cholecystectomy.
- Conditions
- Cholelithiasis
- Being tested
- Ketamine Hydrochloride
- Medical subject headings
- Cholelithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine HydrochlorideDrug
Also called ketasol
Ketamine was given prior to wound closure.
| Study group | Role | What they receive |
|---|---|---|
| Ketamine group (Group K) | Experimental | Group K was given ketamine @ 0.5mg/kg (prepared by dilution in 0.9% normal saline in 10 ml syringe) at the time of wound closure. Receives: Drug: Ketamine Hydrochloride |
| Saline group (Group S) | Other | Group S was given saline in 10 ml syringe Receives: Drug: Ketamine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain score using Visual Analogue scale, ranging from 0 (minimum) and 10 (maximum), 3 and below showing no pain and scores above 3 showing moderate to severe pain.
Change in pain score using Visual Analogue Scale
Measured: Baseline on arrival in the post anaesthesia care unit and then every fifteen minutes unto one hour
Secondary outcomes (1)
narcotic consumption in the post operative anaesthesia care unit
requirement of narcotic in the post anaesthesia care unit
Measured: postoperatively, after arrival in the post anaesthesia care unit at every fifteen minutes unto one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start17 Jan 2013
- Primary completion30 Nov 2013
- Study completion30 Nov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholelithiasisStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized control trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Saima Rashid, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05444777
- Sponsor's protocol ID
- 2387-Ane-ERC-12
- Status last verified
- Jul 2023
- First submitted
- 17 Mar 2021
- Last updated
- 11 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Low Dose Ketamine on Narcotic Consumption in Patients Undergoing Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT05444777
- Acronym / sponsor ID
- 2387-Ane-ERC-12
- Conditions
- Cholelithiasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- 17 Jan 2013 (actual)
- Primary completion
- 30 Nov 2013 (actual)
- Study completion
- 30 Nov 2013 (actual)
- First posted
- 6 Jul 2022 (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.
This double-blinded randomized control trial aims to analyze the effect of low dose Ketamine on narcotic consumption, in patients undergoing Laparoscopic cholecystectomy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Ketamine group (Group K) | Experimental | Drug: Ketamine HydrochlorideGroup K was given ketamine @ 0.5mg/kg (prepared by dilution in 0.9% normal saline in 10 ml syringe) at the time of wound closure. |
| Saline group (Group S) | Other | Drug: Ketamine HydrochlorideGroup S was given saline in 10 ml syringe |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all ASA 1 and 2 patients undergoing Laparoscopic Cholecystectomy electively.
Key exclusion criteria (1 listed)
- Hepatic and renal disease and ASA 3 and 4 patients.
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 HydrochlorideAlso: ketasolKetamine was given prior to wound closure. | Drug | Ketamine group (Group K), Saline group (Group S) |
Primary outcome
pain score using Visual Analogue scale, ranging from 0 (minimum) and 10 (maximum), 3 and below showing no pain and scores above 3 showing moderate to severe pain.
Time frame: Baseline on arrival in the post anaesthesia care unit and then every fifteen minutes unto one hour
Change in pain score using Visual Analogue Scale
1 secondary outcome
narcotic consumption in the post operative anaesthesia care unit
Time frame: postoperatively, after arrival in the post anaesthesia care unit at every fifteen minutes unto one hour
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 11 Jul 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Ketamine Hydrochloride in people with Cholelithiasis, run by Aga Khan University.
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 1 inclusion and 1 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 11 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
pain score using Visual Analogue scale, ranging from 0 (minimum) and 10 (maximum), 3 and below showing no pain and scores above 3 showing moderate to severe pain. (time frame: Baseline on arrival in the post anaesthesia care unit and then every fifteen minutes unto one hour). 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 11 Jul 2023.