Effect of Magnesium Sulfate on Hemodynamics on Laparoscopic Cholecystectomy Patients

NCT ID: NCT07079514

Last Updated: 2025-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-06

Study Completion Date

2025-04-21

Brief Summary

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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.

Detailed Description

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Conditions

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Hemodynamics Instability Pain After Surgery PONV in Laparoscopic Cholocystectomies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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group A

100ml normal saline is used as placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

normal saline in 100ml piggy bag

groupB

3g magnesium sulphate

Group Type ACTIVE_COMPARATOR

Magnesium

Intervention Type 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

Interventions

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Placebo

normal saline in 100ml piggy bag

Intervention Type DRUG

Magnesium

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

Intervention Type DRUG

Other Intervention Names

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MgSo4 Magnesium sulphate

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Known Hypermagnesemia
* Known allergy to Magnesium
* Any degree of Heart Block
* Patients on Calcium Channel Blockers
* Known CKD/AKI
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ziauddin University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr Asma A Salam, MBBS, FCPS

Role: STUDY_CHAIR

Dr Ziauddin Hospital

Locations

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Dr Ziauddin Hospital

Karachi, Sindh, Pakistan

Site Status

Countries

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Pakistan

References

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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

Reference Type 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

Reference Type 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

Reference Type 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.

Reference Type 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.

Reference Type RESULT
PMID: 17513629 (View on PubMed)

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.

Reference Type RESULT
PMID: 25885838 (View on PubMed)

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.

Reference Type RESULT
PMID: 19617379 (View on PubMed)

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.

Reference Type RESULT
PMID: 23904932 (View on PubMed)

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.

Reference Type RESULT
PMID: 22096279 (View on PubMed)

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.

Reference Type RESULT
PMID: 31862004 (View on PubMed)

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.

Reference Type RESULT
PMID: 31303716 (View on PubMed)

Related Links

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https://pubmed.ncbi.nlm.nih.gov/33074990/

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

Other Identifiers

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8840724RHANE

Identifier Type: -

Identifier Source: org_study_id

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