AzTrials
AzTrials

Hemodynamics InstabilityPhase 1/2NCT07079514

Effect of Magnesium Sulfate on Hemodynamics on Laparoscopic Cholecystectomy Patients

A Phase 1/2 study testing Magnesium in people with Hemodynamics Instability and Pain After Surgery, run by Ziauddin University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The goal of this triple blinded randomized control trial is to compare the effect of magnesium sulphate on the hemodynamic response during pneumoperitoneum creation, along with its impact on postoperative pain, opioid consumption, and post operative nausea vomiting (PONV) in ASA I to III patients undergoing… Read more about this study

Who is it for?
Ages 18 to 85 yearsHealthy volunteers can take part
What is being tested?
Magnesium
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 sitePakistan
Study dates
6 Jan 2025to 21 Apr 2025
Phase
Phase 1/2
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 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age 18 to 85
  • Gender: Male /Female
  • ASA status I/II/III
  • Patients undergoing elective Laparoscopic cholecystectomy

Who cannot join

  • Known Hypermagnesemia
  • Known allergy to Magnesium
  • Any degree of Heart Block
  • Patients on Calcium Channel Blockers
  • Known CKD/AKI

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Dr Ziauddin Hospital

    Karachi, Sindh, 75600

Other trials in Pakistan

About this study

Official title: Role of Magnesium Sulphate Versus Placebo on Hemodynamic Changes During Pneumoperitoneum During Laparoscopic Procedures

The goal of this triple blinded randomized control trial is to compare the effect of magnesium sulphate on the hemodynamic response during pneumoperitoneum creation, along with its impact on postoperative pain, opioid consumption, and post operative nausea vomiting (PONV) in ASA I to III patients undergoing laparoscopic cholecystectomy The main question[s] it aims to answer is whether the agent Magnesium Sulphate will blunt the increase in the hemodynamic response during peritoneal insufflation, and will it decrease post operative opioids consumption and prevent nausea vomiting in patients undergoing laparoscopic surgeries.

30 were given placebo and 30 were introduced with magnesium sulphate (3mg) 5 mins before insufflation. The hemodynamic such as, mean arterial pressure (MAP,) systolic (SBP) and diastolic blood pressures (DBP), heart rate (HR) were recorded pre operatively and intraoperatively with intervals of 5mins. Pain score was recorded by VAS scaling and post operative nausea vomiting (PONV) with Yes and No in post operative anesthesia unit (PACU) period.

Being tested
Placebo, Magnesium
Keywords
Pneumoperitoneum, Hemodynamics, Magnesium Sulfate, Pain, PONV
Medical subject headings
Pneumoperitoneum, Pain, Postoperative Nausea and Vomiting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    normal saline in 100ml piggy bag

  • MagnesiumDrug

    Also called MgSo4, Magnesium sulphate

    Magnesium Sulphate will be given as doses of 20-50mg/kg in 2 -3 minutes. In order to standardize the dose in every patient we will be using 3g

Study groups in NCT07079514
Study groupRoleWhat they receive
group APlacebo comparator100ml normal saline is used as placebo
Receives: Drug: Placebo
groupBActive comparator3g magnesium sulphate
Receives: Drug: Magnesium

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in Mean arterial pressures (MAP), Systolic blood pressures (SBP), Diastolic blood pressures (DBP)

    Laparoscopic surgeries, such as cholecystectomy, require CO₂ insufflation to create pneumoperitoneum, which leads to increased sympathetic activity, elevated blood pressure

    Measured: 6 months

  2. Changes in Heart Rate (HR)

    Laparoscopic surgeries, such as cholecystectomy, require CO₂ insufflation to create pneumoperitoneum

    Measured: 6 months

Secondary outcomes (1)

  1. Pain Scores on the Visual Analog SCALE

    magnesium sulfate acts on NMDA receptor and has non opioid pain relieving properties hence we are going to assess whether there's a decrease in post operative pain

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2025
  2. Study start6 Jan 2025
  3. Primary completion21 Apr 2025
  4. Study completion21 Apr 2025

Resources

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 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07079514
Sponsor's protocol ID
8840724RHANE
Status last verified
Jun 2025
First submitted
2 Jul 2025
Last updated
2 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: written consent, demographics, co-morbids, hemodynamic parameters of each patients. duration of surgery, total anesthesia duration, time for which pneumoperitoneum was created.

Publications

  • Shafiq T, Rana MA, Nisar A. Comparison of Hemodynamic Response after Pneumoperitoneum with Versus without Pre-Emptive Magnesium Sulphate in Patients Undergoing Laparoscopic Cholecystectomy. Pakistan Journal of Medical & Health Sciences. 2022 Apr 12;16(03):267

  • Maya G, Ramya N, Anzar S, et al. Effect of magnesium sulfate in attenuating arterial blood pressure in elective laparoscopic abdominal surgeries. J. Evolution Med. Dent. Sci. 2017;6(33):2680-2683, DOI: 10.14260/Jemds/2017/578

  • Zareen A, Gardazi SFA, Anwar MH, Zaheer J. Effects of IV Magnesium Sulphate on Hemodynamic Response to Pneumoperitoneum in Laparoscopic Cholecystectomy; A randomized control. Ann Pak Inst Med Sci. 2021; 17(2):82-85. doi. 10.48036/apims.v17i2.539

  • Murumu DP, Mishra M, Singh AK, Mathur SK. Effect of Magnesium Sulphate on Intra Operative Anesthetic Requirements and Post Operative Analgesia in Plastic Surgery Patients. Int J Anesth Res. 2021 Nov 29;9(03):662-7.

  • Tramer MR, Glynn CJ. An evaluation of a single dose of magnesium to supplement analgesia after ambulatory surgery: randomized controlled trial. Anesth Analg. 2007 Jun;104(6):1374-9, table of contents. doi: 10.1213/01.ane.0000263416.14948.dc.

    PubMed 17513629

  • Paul S, Biswas P, Bhattacharjee DP, Sengupta J. Effects of magnesium sulfate on hemodynamic response to carbon dioxide pneumoperitoneum in patients undergoing laparoscopic cholecystectomy. Anesth Essays Res. 2013 May-Aug;7(2):228-31. doi: 10.4103/0259-1162.118970.

    PubMed 25885838

  • Jee D, Lee D, Yun S, Lee C. Magnesium sulphate attenuates arterial pressure increase during laparoscopic cholecystectomy. Br J Anaesth. 2009 Oct;103(4):484-9. doi: 10.1093/bja/aep196. Epub 2009 Jul 17.

    PubMed 19617379

  • Do SH. Magnesium: a versatile drug for anesthesiologists. Korean J Anesthesiol. 2013 Jul;65(1):4-8. doi: 10.4097/kjae.2013.65.1.4. Epub 2013 Jul 19.

    PubMed 23904932

  • Tripathi DC, Shah KS, Dubey SR, Doshi SM, Raval PV. Hemodynamic stress response during laparoscopic cholecystectomy: Effect of two different doses of intravenous clonidine premedication. J Anaesthesiol Clin Pharmacol. 2011 Oct;27(4):475-80. doi: 10.4103/0970-9185.86586.

    PubMed 22096279

  • Tan W, Qian DC, Zheng MM, Lu X, Han Y, Qi DY. Effects of different doses of magnesium sulfate on pneumoperitoneum-related hemodynamic changes in patients undergoing gastrointestinal laparoscopy: a randomized, double-blind, controlled trial. BMC Anesthesiol. 2019 Dec 20;19(1):237. doi: 10.1186/s12871-019-0886-4.

    PubMed 31862004

  • El Mourad MB, Arafa SK. Effect of intravenous versus intraperitoneal magnesium sulfate on hemodynamic parameters and postoperative analgesia during laparoscopic sleeve gastrectomy-A prospective randomized study. J Anaesthesiol Clin Pharmacol. 2019 Apr-Jun;35(2):242-247. doi: 10.4103/joacp.JOACP_208_18.

    PubMed 31303716

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Magnesium in people with Hemodynamics Instability and Pain After Surgery, run by Ziauddin University 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 4 inclusion and 5 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 2 Sep 2026. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Changes in Mean arterial pressures (MAP), Systolic blood pressures (SBP), Diastolic blood pressures (DBP) (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT07079514, which also lists 11 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 2 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in