Hemodynamics Instability, Pain After Surgery, PONV in Laparoscopic Cholocystectomies
Conditions
Keywords
Pneumoperitoneum, Hemodynamics, Magnesium Sulfate, Pain, PONV
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.
Interventions
DRUGPlacebo
normal saline in 100ml piggy bag
DRUGMagnesium
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
Sponsors
Ziauddin University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Mean arterial pressures (MAP), Systolic blood pressures (SBP), Diastolic blood pressures (DBP) | 6 months | Laparoscopic surgeries, such as cholecystectomy, require CO₂ insufflation to create pneumoperitoneum, which leads to increased sympathetic activity, elevated blood pressure |
| Changes in Heart Rate (HR) | 6 months | Laparoscopic surgeries, such as cholecystectomy, require CO₂ insufflation to create pneumoperitoneum |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Scores on the Visual Analog SCALE | 6 months | 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 |
Countries
Pakistan
Contacts
STUDY_CHAIRDr Asma A Salam, MBBS, FCPS
Dr Ziauddin Hospital
Outcome results
None listed