Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group A | Placebo Comparator | 100ml normal saline is used as placebo |
|
| groupB | Active Comparator | 3g magnesium sulphate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | normal saline in 100ml piggy bag |
| |
| Magnesium |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Mean arterial pressures (MAP), Systolic blood pressures (SBP), Diastolic blood pressures (DBP) | Laparoscopic surgeries, such as cholecystectomy, require COâ‚‚ 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 COâ‚‚ insufflation to create pneumoperitoneum | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| YES/NO questionnaire for Post operative nausea vomiting | post operative nausea vomiting assessment will through yes or no questionnaire | 6 months |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dr Asma A Salam, MBBS, FCPS | Dr Ziauddin Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr Ziauddin Hospital | Karachi | Sindh | 75600 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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. | ||
| 17513629 |
| Label | URL |
|---|---|
| Effectiveness of intravenous magnesium sulfate to attenuate hemodynamic changes in laparoscopic surgery: a systematic review and meta-analysis | View source |
Not provided
written consent, demographics, co-morbids, hemodynamic parameters of each patients. duration of surgery, total anesthesia duration, time for which pneumoperitoneum was created.
6 months
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011027 | Pneumoperitoneum |
| D010146 | Pain |
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D010532 | Peritoneal Diseases |
| D004066 | Digestive System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D008274 | Magnesium |
| D008278 | Magnesium Sulfate |
| ID | Term |
|---|---|
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D019565 | Metals, Light |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
|
|
| 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. |
| 25885838 | 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. |
| 19617379 | 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. |
| 23904932 | 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. |
| 22096279 | 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. |
| 31862004 | 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. |
| 31303716 | 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. |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D009325 | Nausea |
| D012817 | Signs and Symptoms, Digestive |
| D014839 | Vomiting |
| D008670 |
| Metals |
| D017616 | Magnesium Compounds |
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |