Laparoscopic Cholecystectomy SurgeryPhase 1NCT07248358
The Efface of Ketamine vs. Magnesium Sulphate in the Management of Pain After Laparoscopic Cholecystectomy
A Phase 1 study testing IV ketamine 0.5 mg/kg and IV 2mg of Magnesium Sulphate in people with Laparoscopic Cholecystectomy Surgery and Postoperative Pain Management, run by Liaquat National Hospital & Medical College at 1 site in Pakistan.
Trial summary
This prospective interventional study was conducted at Liaquat National Hospital and Medical College to compare the postoperative analgesic effects of ketamine and magnesium sulphate in patients undergoing laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Laparoscopic Cholecystectomy Surgery, Postoperative Pain Management
- What is being tested?
- IV ketamine 0.5 mg/kg and IV 2mg of Magnesium Sulphate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jun 2023to 20 Oct 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA physical status I-II. Elective laparoscopic cholecystectomy planned under general anesthesia. Normal baseline renal, hepatic, and coagulation profile. Able to give informed consent and communicate pain scores. Negative pregnancy test for women of childbearing age.
Who cannot join
- Allergy or hypersensitivity to ketamine, magnesium sulphate, or related drugs. History of psychiatric illness or substance abuse. Chronic use of opioids, benzodiazepines, or MAO inhibitors. Pregnant or breastfeeding women. Chronic pain disorders or use of analgesics within 7 days pre-op. Major hepatic, renal, or cardiovascular dysfunction. History of myopathy or seizure disorders. Patients with atrioventricular block or on calcium-channel blockers. Conversion to open cholecystectomy during surgery
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Anesthesiology Department Liaquat National Hospital and Medical College
Karachi, Sindh, 78400
About this study
Official title: The Efface of Ketamine vs. Magnesium Sulphate in the Management of Pain After Laparoscopic Cholecystectomy: A Randomized Controlled Trial
This prospective interventional study was conducted at Liaquat National Hospital and Medical College to compare the postoperative analgesic effects of ketamine and magnesium sulphate in patients undergoing laparoscopic cholecystectomy. A total of 78 ASA I-II patients were included and randomly allocated into two equal groups (39 patients in each group) using a sealed-envelope technique. One group received ketamine, while the other received magnesium sulphate, following a standardized intraoperative anesthesia protocol. All patients were provided routine postoperative medications according to institutional practice. Pain scores were recorded using the Visual Analogue Scale (VAS) at 1, 6, 12, and 24 hours after surgery. The objective of this study was to determine which drug offered better postoperative pain relief, thereby contributing to improved analgesic strategies for patients undergoing laparoscopic cholecystectomy.
Read the detailed description
Effective postoperative pain control plays a crucial role in accelerating recovery, minimizing physiological stress, and improving patient satisfaction after laparoscopic cholecystectomy. This prospective interventional study was carried out in the Department of Anesthesiology at Liaquat National Hospital and Medical College to evaluate and compare the analgesic benefits of intravenous ketamine and magnesium sulphate in adults undergoing elective laparoscopic cholecystectomy.
A total of 78 patients classified as ASA I and II with uncomplicated symptomatic gallstones were recruited after obtaining ethical approval and written informed consent. The study was conducted in a double-blinded, participants were randomized into two groups through a sealed-envelope technique: Group K (n = 39) received ketamine, while Group M (n = 39) received magnesium sulphate adding both of the intervention were active drug agent. Patients with ASA III-V, chronic pain disorders, psychiatric illness, pregnancy or breastfeeding status, significant hepatic, renal, or cardiac impairment, or recent use of opioids or NSAIDs were excluded.
All enrolled individuals underwent routine preoperative evaluation and overnight fasting. General anesthesia was induced with propofol and atracurium and maintained with isoflurane, with continuous monitoring of vital parameters including heart rate, non-invasive blood pressure, ECG, oxygen saturation, and end-tidal CO₂. At the completion of surgery, neuromuscular blockade was reversed with neostigmine. Standard postoperative medications consisted of intravenous diclofenac sodium every 8 hours for background analgesia, along with ondansetron for nausea prophylaxis.
Postoperative pain levels were documented using the Visual Analogue Scale (VAS) at 1, 6, 12, and 24 hours following surgery. Patients who experienced significant pain were administered intravenous Kinz 5 mg as rescue analgesia, with administration times recorded by nursing personnel.
This study offered meaningful evidence regarding the comparative analgesic performance of ketamine and magnesium sulphate in the early postoperative period after laparoscopic cholecystectomy. The findings support their potential utility as part of a multimodal analgesic approach aimed at improving patient comfort and enhancing postoperative recovery.
- Being tested
- IV ketamine 0.5 mg/kg, IV 2mg of Magnesium Sulphate
- Keywords
- ketamine, magnesium sulphate, Laparoscopic Cholecystectomy, Pain, Postoperative Pain, Anesthesia
- Medical subject headings
- Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV ketamine 0.5 mg/kgDrug
Here is a rewritten and unbolded version of your paragraph:
---
Patients in the ketamine group were given intravenous ketamine at a dose of 0.5 mg/kg of body weight, diluted with normal saline to a total volume of 10 mL. The solution was administered as a single intravenous injection at the time of anesthesia reversal, immediately after completion of laparoscopic cholecystectomy. The drug was given under aseptic conditions by an anesthetist who was unaware of group allocation. All patients received standard postoperative care, including intravenous diclofenac sodium 75 mg every 8 hours for baseline analgesia and intravenous ondansetron 4 mg for nausea prophylaxis. Postoperative pain was assessed at 1, 6, 12, and 24 hours using the Visual Analogue Scale (VAS). Patients reporting significant pain were given intravenous Kinz 5 mg as rescue analgesia, with the timing of administration recorded.
IV 2mg of Magnesium SulphateDrug
Patients in the magnesium sulfate group received 2 mg of the drug, which was diluted with normal saline to a total volume of 10 mL and administered intravenously as a single stat dose at the time of anesthesia reversal following completion of laparoscopic cholecystectomy. The injection was performed under aseptic conditions by an anesthetist who was blinded to group assignment. All participants received routine postoperative care, including intravenous diclofenac sodium 75 mg every 8 hours for baseline pain control and intravenous ondansetron 4 mg to prevent nausea. Postoperative pain intensity was measured using the Visual Analogue Scale (VAS) at 1, 6, 12, and 24 hours. Patients experiencing significant pain were given intravenous Kinz 5 mg as rescue analgesia, and the timing of administration was recorded for documentation.
| Study group | Role | What they receive |
|---|---|---|
| Ketamine Group | Active comparator | The ketamine dose was prepared at 0.5 mg/kg of body weight, diluted with normal saline to make a total volume of 10 mL, and administered intravenously as a single bolus during anesthesia reversal after the surgery was completed. Receives: Drug: IV ketamine 0.5 mg/kg |
| Magnesium Sulphate | Active comparator | The magnesium sulfate dose was prepared as 2 mg, diluted with normal saline to a total volume of 10 mL, and administered intravenously as a single stat dose at the time of anesthesia reversal after completion of surgery. Receives: Drug: IV 2mg of Magnesium Sulphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Score
Postoperative pain was evaluated using the Visual Analogue Scale (VAS) at 1, 6, 12, and 24 hours after surgery to compare the efficacy and duration of analgesia between the ketamine and lidocaine groups. These time points were chosen to capture both early and late pain responses within the first 24 hours of recovery.
Measured: Postoperative pain was assessed at the 1st, 6th, 12th, and 24th hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start15 Jun 2023
- Primary completion15 Sep 2025
- Study completion20 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic Cholecystectomy SurgeryStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liaquat National Hospital & Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Hussain Imam, Liaquat National Hospital & Medical College
- Investigators
- Ali Asgher, Mbbs, FCPS, Study director, Liaquat National Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07248358
- Sponsor's protocol ID
- 1096-2024-LNH-ERC
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 25 Nov 2025
- 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 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efface of Ketamine vs. Magnesium Sulphate in the Management of Pain After Laparoscopic Cholecystectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07248358
- Acronym / sponsor ID
- 1096-2024-LNH-ERC
- Keywords
- ketamine, magnesium sulphate, Laparoscopic Cholecystectomy, Pain, Postoperative Pain, Anesthesia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Liaquat National Hospital & Medical CollegeUniversity, hospital or other
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 15 Sep 2025 (actual)
- Study completion
- 20 Oct 2025 (actual)
- First posted
- 25 Nov 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.
This prospective interventional study was conducted at Liaquat National Hospital and Medical College to compare the postoperative analgesic effects of ketamine and magnesium sulphate in patients undergoing laparoscopic cholecystectomy. A total of 78 ASA I-II patients were included and randomly allocated into two equal groups (39 patients in each group) using a sealed-envelope technique. One group received ketamine, while the other received magnesium sulphate, following a standardized intraoperative anesthesia protocol. All patients were provided routine postoperative medications according to institutional practice. Pain scores were recorded using the Visual Analogue Scale (VAS) at 1, 6, 12, and 24 hours after surgery. The objective of this study was to determine which drug offered better postoperative pain relief, thereby contributing to improved analgesic strategies for patients undergoing laparoscopic cholecystectomy.
Detailed description
Effective postoperative pain control plays a crucial role in accelerating recovery, minimizing physiological stress, and improving patient satisfaction after laparoscopic cholecystectomy. This prospective interventional study was carried out in the Department of Anesthesiology at Liaquat National Hospital and Medical College to evaluate and compare the analgesic benefits of intravenous ketamine and magnesium sulphate in adults undergoing elective laparoscopic cholecystectomy.
A total of 78 patients classified as ASA I and II with uncomplicated symptomatic gallstones were recruited after obtaining ethical approval and written informed consent. The study was conducted in a double-blinded, participants were randomized into two groups through a sealed-envelope technique: Group K (n = 39) received ketamine, while Group M (n = 39) received magnesium sulphate adding both of the intervention were active drug agent. Patients with ASA III-V, chronic pain disorders, psychiatric illness, pregnancy or breastfeeding status, significant hepatic, renal, or cardiac impairment, or recent use of opioids or NSAIDs were excluded.
All enrolled individuals underwent routine preoperative evaluation and overnight fasting. General anesthesia was induced with propofol and atracurium and maintained with isoflurane, with continuous monitoring of vital parameters including heart rate, non-invasive blood pressure, ECG, oxygen saturation, and end-tidal CO₂. At the completion of surgery, neuromuscular blockade was reversed with neostigmine. Standard postoperative medications consisted of intravenous diclofenac sodium every 8 hours for background analgesia, along with ondansetron for nausea prophylaxis.
Postoperative pain levels were documented using the Visual Analogue Scale (VAS) at 1, 6, 12, and 24 hours following surgery. Patients who experienced significant pain were administered intravenous Kinz 5 mg as rescue analgesia, with administration times recorded by nursing personnel.
This study offered meaningful evidence regarding the comparative analgesic performance of ketamine and magnesium sulphate in the early postoperative period after laparoscopic cholecystectomy. The findings support their potential utility as part of a multimodal analgesic approach aimed at improving patient comfort and enhancing postoperative recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine Group | Active comparator | Drug: IV ketamine 0.5 mg/kgThe ketamine dose was prepared at 0.5 mg/kg of body weight, diluted with normal saline to make a total volume of 10 mL, and administered intravenously as a single bolus during anesthesia reversal after the surgery was completed. |
| Magnesium Sulphate | Active comparator | Drug: IV 2mg of Magnesium SulphateThe magnesium sulfate dose was prepared as 2 mg, diluted with normal saline to a total volume of 10 mL, and administered intravenously as a single stat dose at the time of anesthesia reversal after completion of surgery. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA physical status I-II. Elective laparoscopic cholecystectomy planned under general anesthesia. Normal baseline renal, hepatic, and coagulation profile. Able to give informed consent and communicate pain scores. Negative pregnancy test for women of childbearing age.
Key exclusion criteria (1 listed)
- Allergy or hypersensitivity to ketamine, magnesium sulphate, or related drugs. History of psychiatric illness or substance abuse. Chronic use of opioids, benzodiazepines, or MAO inhibitors. Pregnant or breastfeeding women. Chronic pain disorders or use of analgesics within 7 days pre-op. Major hepatic, renal, or cardiovascular dysfunction. History of myopathy or seizure disorders. Patients with atrioventricular block or on calcium-channel blockers. Conversion to open cholecystectomy during surgery
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 |
|---|---|---|
| IV ketamine 0.5 mg/kgHere is a rewritten and unbolded version of your paragraph: --- Patients in the ketamine group were given intravenous ketamine at a dose of 0.5 mg/kg of body weight, diluted with normal saline to a total volume of 10 mL. The solution was administered as a single intravenous injection at the time of anesthesia reversal, immediately after completion of laparoscopic cholecystectomy. The drug was given under aseptic conditions by an anesthetist who was unaware of group allocation. All patients received standard postoperative care, including intravenous diclofenac sodium 75 mg every 8 hours for baseline analgesia and intravenous ondansetron 4 mg for nausea prophylaxis. Postoperative pain was assessed at 1, 6, 12, and 24 hours using the Visual Analogue Scale (VAS). Patients reporting significant pain were given intravenous Kinz 5 mg as rescue analgesia, with the timing of administration recorded. | Drug | Ketamine Group |
| IV 2mg of Magnesium SulphatePatients in the magnesium sulfate group received 2 mg of the drug, which was diluted with normal saline to a total volume of 10 mL and administered intravenously as a single stat dose at the time of anesthesia reversal following completion of laparoscopic cholecystectomy. The injection was performed under aseptic conditions by an anesthetist who was blinded to group assignment. All participants received routine postoperative care, including intravenous diclofenac sodium 75 mg every 8 hours for baseline pain control and intravenous ondansetron 4 mg to prevent nausea. Postoperative pain intensity was measured using the Visual Analogue Scale (VAS) at 1, 6, 12, and 24 hours. Patients experiencing significant pain were given intravenous Kinz 5 mg as rescue analgesia, and the timing of administration was recorded for documentation. | Drug | Magnesium Sulphate |
Primary outcome
Postoperative Pain Score
Time frame: Postoperative pain was assessed at the 1st, 6th, 12th, and 24th hours
Postoperative pain was evaluated using the Visual Analogue Scale (VAS) at 1, 6, 12, and 24 hours after surgery to compare the efficacy and duration of analgesia between the ketamine and lidocaine groups. These time points were chosen to capture both early and late pain responses within the first 24 hours of recovery.
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 25 Nov 2025.
- 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.
Ali Asgher, Mbbs, FCPS study director
Liaquat National Hospital
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 IV ketamine 0.5 mg/kg and IV 2mg of Magnesium Sulphate in people with Laparoscopic Cholecystectomy Surgery and Postoperative Pain Management, run by Liaquat National Hospital & 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 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 25 Nov 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. 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?
Postoperative Pain Score (time frame: Postoperative pain was assessed at the 1st, 6th, 12th, and 24th hours). 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 25 Nov 2025.