Laparoscopic CholecystectomyPhase 1NCT06966596
Low-Dose Ketamine Infusion for Post-Operative Pain in Patients Undergoing Laparoscopic Cholecyctectomy
A Phase 1 study testing Ketamine only in people with Laparoscopic Cholecystectomy, run by Fazaia Ruth Pfau Medical College at 1 site in Pakistan.
Trial summary
Following surgery, acute pain is a typical issue with a variety of implications. Surgeons, anesthesia specialists, and patients all desire effective pain management with the fewest possible adverse effects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laparoscopic Cholecystectomy
- What is being tested?
- Ketamine only
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2024to 31 Mar 2025
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of age 18 years or above of either gender
- Patients planned of elective laparoscopic choleycyctectomy
Who cannot join
- Obese patients
- History of alcohol consumption and drug abusers
- Uncontrolled hypertension
- Uncontrolled diabetes
- Patients with chronic pain
- Patients allergic to study drugs
- Patients with neurological disorders
- Patients unable to understand scoring system
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Fazaia Ruth Pfau Medical College, PAF Hospital Base Faisal
Karachi
About this study
Official title: Effect of Low-Dose Ketamine Infusion on Quality and Duration of Post-Operative Pain in Patients Undergoing Laparoscopic Cholecyctectomy Under General Anesthesia
Following surgery, acute pain is a typical issue with a variety of implications. Surgeons, anesthesia specialists, and patients all desire effective pain management with the fewest possible adverse effects. At low dosages (<0.3 mg/kg/hr) and large doses (>1 mg/kg), ketamine is utilized as an analgesic and an anaesthetic. Ketamine at high dosages causes dissociative anaesthesia with little impact on breathing or airway reflexes. Although this medication is a powerful analgesic, its usage is restricted due to it leads to agitation and hallucinations during awakening. Nevertheless, it has a potent analgesic effect when administered at a subanesthetic dose, and ketamine's psychomimetic side effects are rare at these dosages. This study intended to examine the role of low-dose for post-operative pain control in patients undergoing LC, despite the fact that numerous studies have been conducted on the subject and that the results have been inconsistent.
Read the detailed description
Most patients still stay overnight after a laparoscopic cholecystectomy (LC) due to post-operative pain, which continues to be the principal obstacle to early patient discharge. On the first postoperative day following laparoscopic procedures, patients may have mild to moderate postoperative pain, with decreased pain intensity in the shoulder area (from the subdiaphragmatic region), particularly intra-abdominal and local discomfort at the incision site. Because of its analgesic properties and cardiovascular stability, ketamine has been used extensively in anesthesia practice. It non-competitively blocks N-methyl-D-aspartate (NMDA) receptors. As an addition to multimodal perioperative pain management, ketamine has grown in favor in recent years. Ketamine at high dosages causes dissociative anaesthesia with little impact on breathing or airway reflexes. In a range of surgical procedures, low-dose ketamine infusions (<0.3 mg/kg/hr) have demonstrated effectiveness in lowering pain scores and minimising the need for postoperative opioids. Regarding the reduction of pain and analgesic demand, ketamine has demonstrated conflicting effects. The study objective was to determine the effect of low-dose ketamine infusion on quality and duration of post-operative pain in patients undergoing laparoscopic in a tertiary care hospital.
- Conditions
- Laparoscopic Cholecystectomy
- Being tested
- Ketamine only, Placebo Normal Saline (NS)
- Keywords
- Cholelithiasis, Cholecystectomy, Laparoscopic surgery, Ketamine, Analgesia
- Medical subject headings
- Cholelithiasis, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine onlyDrug
Group A received ketamineat 0.2mg/kg bolus intravenously followed by ketamine infusion at rate of 0.2mg/kg/hr throughout the surgery. W
Placebo Normal Saline (NS)Other
Control group received normal saline to maintain double blinding
| Study group | Role | What they receive |
|---|---|---|
| Group A received ketamineat 0.2mg/kg bolus intravenously followed by ketamine infusion at rate of 0. | Experimental | Group A received ketamineat 0.2mg/kg bolus intravenously followed by ketamine infusion at rate of 0.2mg/kg/hr throughout the surgery. Receives: Drug: Ketamine only |
| Control Group B | Placebo comparator | Control group received normal saline intravenously at an equivalent infusion rate Receives: Other: Placebo Normal Saline (NS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-pain assessment
pain was assessed using numeric rating scale which is a ten point scoring scale ranging from 0-10 for ranking pain where 0 means no pain and 10 means worst pain.
Measured: pain status was monitored post-operatively at 0 hour, 2 hour, 4 hours, 6 hours, 12 hours and at 24 hours
Secondary outcomes (1)
time to rescue analgesia
time to rescue analgesia was defined as time point at which patient was given rescue analgesia for pain score of 5 or above
Measured: till 24 hours post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start1 Nov 2024
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic CholecystectomyStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fazaia Ruth Pfau Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Syeda Hajrah Rehman, Fazaia Ruth Pfau Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06966596
- Sponsor's protocol ID
- FPRMC-IRB-2024-38
- Status last verified
- May 2025
- First submitted
- 4 May 2025
- Last updated
- 22 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is institutional data which has to be concealed for patient's privacy
Publications
Jain S, Nazir N, Mustafi SM. Preemptive low-dose intravenous ketamine in the management of acute and chronic postoperative pain following laparoscopic cholecystectomy: a prospective randomized control study. Med Gas Res. 2022 Oct-Dec;12(4):141-145. doi: 10.4103/2045-9912.337995.
PubMed 35435425Akturk R, Serinsoz S. Determining a Method to Minimize Pain After Laparoscopic Cholecystectomy Surgery. Surg Laparosc Endosc Percutan Tech. 2022 Aug 1;32(4):441-448. doi: 10.1097/SLE.0000000000001071.
PubMed 35797664Gin E, Lowen D, Tacey M, Hodgson R. Reduced Laparoscopic Intra-abdominal Pressure During Laparoscopic Cholecystectomy and Its Effect on Post-operative Pain: a Double-Blinded Randomised Control Trial. J Gastrointest Surg. 2021 Nov;25(11):2806-2813. doi: 10.1007/s11605-021-04919-0. Epub 2021 Feb 9.
PubMed 33565010
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low-Dose Ketamine Infusion on Quality and Duration of Post-Operative Pain in Patients Undergoing Laparoscopic Cholecyctectomy Under General Anesthesia
- ClinicalTrials.gov ID
- NCT06966596
- Acronym / sponsor ID
- FPRMC-IRB-2024-38
- Conditions
- Laparoscopic Cholecystectomy
- Keywords
- Cholelithiasis, Cholecystectomy, Laparoscopic surgery, Ketamine, Analgesia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Fazaia Ruth Pfau Medical CollegeUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 13 May 2025 (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.
Following surgery, acute pain is a typical issue with a variety of implications. Surgeons, anesthesia specialists, and patients all desire effective pain management with the fewest possible adverse effects. At low dosages (<0.3 mg/kg/hr) and large doses (>1 mg/kg), ketamine is utilized as an analgesic and an anaesthetic. Ketamine at high dosages causes dissociative anaesthesia with little impact on breathing or airway reflexes. Although this medication is a powerful analgesic, its usage is restricted due to it leads to agitation and hallucinations during awakening. Nevertheless, it has a potent analgesic effect when administered at a subanesthetic dose, and ketamine's psychomimetic side effects are rare at these dosages. This study intended to examine the role of low-dose for post-operative pain control in patients undergoing LC, despite the fact that numerous studies have been conducted on the subject and that the results have been inconsistent.
Detailed description
Most patients still stay overnight after a laparoscopic cholecystectomy (LC) due to post-operative pain, which continues to be the principal obstacle to early patient discharge. On the first postoperative day following laparoscopic procedures, patients may have mild to moderate postoperative pain, with decreased pain intensity in the shoulder area (from the subdiaphragmatic region), particularly intra-abdominal and local discomfort at the incision site. Because of its analgesic properties and cardiovascular stability, ketamine has been used extensively in anesthesia practice. It non-competitively blocks N-methyl-D-aspartate (NMDA) receptors. As an addition to multimodal perioperative pain management, ketamine has grown in favor in recent years. Ketamine at high dosages causes dissociative anaesthesia with little impact on breathing or airway reflexes. In a range of surgical procedures, low-dose ketamine infusions (<0.3 mg/kg/hr) have demonstrated effectiveness in lowering pain scores and minimising the need for postoperative opioids. Regarding the reduction of pain and analgesic demand, ketamine has demonstrated conflicting effects. The study objective was to determine the effect of low-dose ketamine infusion on quality and duration of post-operative pain in patients undergoing laparoscopic in a tertiary care hospital.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A received ketamineat 0.2mg/kg bolus intravenously followed by ketamine infusion at rate of 0. | Experimental | Drug: Ketamine onlyGroup A received ketamineat 0.2mg/kg bolus intravenously followed by ketamine infusion at rate of 0.2mg/kg/hr throughout the surgery. |
| Control Group B | Placebo comparator | Other: Placebo Normal Saline (NS)Control group received normal saline intravenously at an equivalent infusion rate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients of age 18 years or above of either gender
- Patients planned of elective laparoscopic choleycyctectomy
Key exclusion criteria (8 listed)
- Obese patients
- History of alcohol consumption and drug abusers
- Uncontrolled hypertension
- Uncontrolled diabetes
- Patients with chronic pain
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 onlyGroup A received ketamineat 0.2mg/kg bolus intravenously followed by ketamine infusion at rate of 0.2mg/kg/hr throughout the surgery. W | Drug | Group A received ketamineat 0.2mg/kg bolus intravenously followed by ketamine infusion at rate of 0. |
| Placebo Normal Saline (NS)Control group received normal saline to maintain double blinding | Other | Control Group B |
Primary outcome
Post-pain assessment
Time frame: pain status was monitored post-operatively at 0 hour, 2 hour, 4 hours, 6 hours, 12 hours and at 24 hours
pain was assessed using numeric rating scale which is a ten point scoring scale ranging from 0-10 for ranking pain where 0 means no pain and 10 means worst pain.
1 secondary outcome
time to rescue analgesia
Time frame: till 24 hours post-operatively
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 22 May 2025.
- Background: PubMed 35435425Jain S, Nazir N, Mustafi SM. Preemptive low-dose intravenous ketamine in the management of acute and chronic postoperative pain following laparoscopic cholecystectomy: a prospective randomized control study. Med Gas Res. 2022 Oct-Dec;12(4):141-145. doi: 10.4103/2045-9912.337995.
- Background: PubMed 35797664Akturk R, Serinsoz S. Determining a Method to Minimize Pain After Laparoscopic Cholecystectomy Surgery. Surg Laparosc Endosc Percutan Tech. 2022 Aug 1;32(4):441-448. doi: 10.1097/SLE.0000000000001071.
- Background: PubMed 33565010Gin E, Lowen D, Tacey M, Hodgson R. Reduced Laparoscopic Intra-abdominal Pressure During Laparoscopic Cholecystectomy and Its Effect on Post-operative Pain: a Double-Blinded Randomised Control Trial. J Gastrointest Surg. 2021 Nov;25(11):2806-2813. doi: 10.1007/s11605-021-04919-0. Epub 2021 Feb 9.
- Individual participant dataSharing planned: No. This is institutional data which has to be concealed for patient's privacy
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ketamine only in people with Laparoscopic Cholecystectomy, run by Fazaia Ruth Pfau Medical College at 1 site in Pakistan.
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 2 inclusion and 8 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 22 May 2025. 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 Pakistan. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Post-pain assessment (time frame: pain status was monitored post-operatively at 0 hour, 2 hour, 4 hours, 6 hours, 12 hours and at 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06966596, which also lists 3 linked publications.
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 22 May 2025.