Effect of Magnesium Sulfate on Hemodynamics on Laparoscopic Cholecystectomy Patients

NCT07079514 | Completed Phase 1 DMC

• 1 other identifier: 8840724RHANE
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Hemodynamics Instability; Pain After Surgery; PONV in Laparoscopic Cholocystectomies

Keywords

Pneumoperitoneum; Hemodynamics; Magnesium Sulfate; Pain; PONV

Outcome Measures

Primary Outcomes (2)

• 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

  6 months

• Changes in Heart Rate (HR)

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

  6 months

Secondary Outcomes (1)

• Pain Scores on the Visual Analog SCALE

  6 months

Other Outcomes (1)

• YES/NO questionnaire for Post operative nausea vomiting

  6 months

Study Arms (2)

group A

PLACEBO COMPARATOR

100ml normal saline is used as placebo

Drug: Placebo

groupB

ACTIVE COMPARATOR

3g magnesium sulphate

Drug: Magnesium

Interventions

Placebo DRUG

normal saline in 100ml piggy bag

group A

Magnesium DRUG

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

Also known as: MgSo4, Magnesium sulphate

groupB

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ziauddin University: lead

Study Sites (1)

Dr Ziauddin Hospital

Karachi, Sindh, 75600, Pakistan

Location

Related Publications (11)

• 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

  RESULT

• 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

  RESULT

• 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

  RESULT

• 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.

  RESULT

• 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.

  PMID: 17513629 RESULT

• 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.

  PMID: 25885838 RESULT

• 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.

  PMID: 19617379 RESULT

• 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.

  PMID: 23904932 RESULT

• 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.

  PMID: 22096279 RESULT

• 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.

  PMID: 31862004 RESULT

• 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.

  PMID: 31303716 RESULT

Related Links

• Effectiveness of intravenous magnesium sulfate to attenuate hemodynamic changes in laparoscopic surgery: a systematic review and meta-analysis

MeSH Terms

Conditions

Pneumoperitoneum; Pain; Postoperative Nausea and Vomiting

Interventions

Magnesium; Magnesium Sulfate

Condition Hierarchy (Ancestors)

Peritoneal Diseases; Digestive System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Nausea; Signs and Symptoms, Digestive; Vomiting

Intervention Hierarchy (Ancestors)

Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals, Light; Metals; Magnesium Compounds; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Dr Asma A Salam, MBBS, FCPS

  Dr Ziauddin Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 23, 2025
• Study Start: January 6, 2025
• Primary Completion: April 21, 2025
• Study Completion: April 21, 2025
• Last Updated: July 23, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 6 months

Locations

PA (1)