- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02508857
Magnesium Sulfate Improves Postoperative Analgesia in Laparoscopic Gynecologic Surgeries (Magnesium)
Magnesium Sulfate Improves Postoperative Analgesia in Laparoscopic Gynecologic Surgeries: a Double-blind Randomized Controlled Trial.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Sixty American Society of Anesthesiologists (ASA) I-II patients undergoing laparoscopic gynecologic oncology surgeries are enrolled in this study.
Patients were randomized to receive either intravenous ketorolac 30 mg in bolus followed by saline infusion (Group K), intravenous magnesium sulfate 20 mg/kg in bolus followed by magnesium 2 mg/kg/h (Group M) or intravenous saline solution 20 ml in bolus followed by saline infusion during the entire procedure (Group S). The study use a double-blinded methodology with random allocation into three groups using sealed opaque envelopes numbered 1 to 60, containing the instructions for the study. An independent anesthesiologist not involved in the study prepared the solutions and an observer who was also blinded to the patient's group records the data.
In the preoperative visit, patients that agree to participate are instructed about numeric rating scale (NRS) and the Patient Controlled Analgesia (PCA) device.
The night before surgery, patients are premedicated with midazolam 7.5 mg per os. Upon arrival in the operating room, monitoring devices (ECG, non-invasive arterial pressure, capnography, pulse oximetry) and a bispectral index (BIS) monitor are established. An intravenous line is secured, general intravenous anesthesia is induced with target infusion remifentanil and propofol. Cisatracurium besylate (0.5 mg/kg) is given to facilitate tracheal intubation and controlled ventilation is adjusted to maintain normocapnia with a 50% oxygen fraction administered. Then, the study medications are administered in bolus during 20 minutes, followed by continuous infusion of the specific solution, according to the study group to which the patient belonged, as described before.
At the end of the surgery, the study drugs are discontinued before the patient is extubated. If patients present clinical signs of residual neuromuscular blockade, they receive atropine 0.01mg/kg and neostigmine 0.04mg/kg. All patients receive dipyrone 30 mg/kg in bolus and a PCA device is connected to the intravenous line before discharge to the Post Anesthesia Care Unit (PACU). PCA solution containing morphine 1mg/ml in 0.9% saline, is set to give bolus of 2ml (2mg) with a 10min lockout interval.
In the postoperative period, the anesthesiologist responsible for the study question the intensity of pain in the patients using two methods: numerical rating scale (NRS) (0=no pain and 10=worst pain imaginable) and descriptive verbal scale (no pain, mild pain, moderate pain or severe pain - at emergence from anesthesia and after 20, 30 and 60 minutes, while in PACU. Patients are instructed to use the PCA device whenever they feel pain. Agitation and Sedation are monitored using RASS scale and patient is considered sedated if RASS ≤ -1. Episodes of nausea, vomiting, respiratory depression or pruritus are also recorded.
Patients are discharged to the ward after 60 minutes, if minimum criteria for discharge are met.
Time (in minutes) to the first morphine rescue, and total consumption of morphine in PACU are registered. After 24 hours, pain intensity score, total morphine consumption and side effects are also recorded and PCA device is disconnected.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
São Paulo
-
Sao Paulo, São Paulo, Brazil, 01403010
- Angela Maria Sousa
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- ASA I-II female patients undergoing laparoscopic gynecologic oncology surgeries, for treatment of cancer
Exclusion Criteria:
- chronic pain, cardiovascular, hepatic or renal disease, neuromuscular disease, diabetes, drugs or alcohol abuse, obesity, patients treated with calcium channel blockers or magnesium, allergy or contraindication to any of the drugs studied.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: ketorolac
intravenous ketorolac (30 mg) is injected in bolus, followed by continuous infusion of saline solution (Group K) during the surgical procedure
|
Patients received intravenous injection of ketorolac (30 mg) in bolus; then, saline solution was continuously infused during the entire procedure (Group K),
Other Names:
|
EXPERIMENTAL: magnesium
intravenous magnesium sulfate (20 mg/kg) is injected in bolus, followed by continuous infusion of magnesium sulfate (2 mg/kg/h) (Group M) during the surgical procedure
|
Patients received intravenous magnesium sulfate (20 mg/kg) in bolus, then magnesium sulfate (2 mg/kg/h) was continuously injected during the procedure (Group M)
Other Names:
|
PLACEBO_COMPARATOR: saline
intravenous saline solution (20 ml) is injected in bolus, followed by continuous infusion of saline infusion during the entire procedure (Group S).
|
intravenous saline solution (20 ml) was injected in bolus, followed by continuous infusion of saline solution during the entire procedure (Group S).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
postoperative pain
Time Frame: 24 hours
|
intensity of pain in the patients using numerical rating scale (NRS) (0=no pain and 10=worst pain imaginable) and descriptive verbal scale (no pain, mild pain, moderate pain or severe pain
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
time to first morphine rescue
Time Frame: first 6 hours
|
Time (in minutes) to the first dose of morphine
|
first 6 hours
|
morphine consumption
Time Frame: 60 minutes
|
total consumption of morphine in PACU
|
60 minutes
|
Collaborators and Investigators
Investigators
- Principal Investigator: angela m sousa, phD, Cancer Institute of the State of São Paulo
Publications and helpful links
General Publications
- Albrecht E, Kirkham KR, Liu SS, Brull R. Peri-operative intravenous administration of magnesium sulphate and postoperative pain: a meta-analysis. Anaesthesia. 2013 Jan;68(1):79-90. doi: 10.1111/j.1365-2044.2012.07335.x. Epub 2012 Nov 1.
- De Oliveira GS Jr, Castro-Alves LJ, Khan JH, McCarthy RJ. Perioperative systemic magnesium to minimize postoperative pain: a meta-analysis of randomized controlled trials. Anesthesiology. 2013 Jul;119(1):178-90. doi: 10.1097/ALN.0b013e318297630d.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Pain, Postoperative
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anesthetics
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Membrane Transport Modulators
- Anticonvulsants
- Calcium-Regulating Hormones and Agents
- Reproductive Control Agents
- Calcium Channel Blockers
- Tocolytic Agents
- Ketorolac
- Magnesium Sulfate
Other Study ID Numbers
- NP0792010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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