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Magnesium Sulfate Improves Postoperative Analgesia in Laparoscopic Gynecologic Surgeries (Magnesium)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02508857
Recruitment Status : Completed
First Posted : July 27, 2015
Last Update Posted : July 27, 2015
Sponsor:
Information provided by (Responsible Party):
Instituto do Cancer do Estado de São Paulo

Brief Summary:
Magnesium sulfate has been reported to improve postoperative pain, but evidence is still controversial. Some studies demonstrated benefits while others concluded that there is no efficacy. Aim: the aim of the study was to compare the effect of intravenous infusion of magnesium sulfate to ketorolac during laparoscopic gynecologic oncology surgeries. Methods: We designed a double-blind randomized controlled trial that compared intravenous magnesium sulfate to ketorolac and saline solution in postoperative pain, morphine consumption and opioid related side effects.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: Ketorolac Drug: Magnesium Drug: Saline solution Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Magnesium Sulfate Improves Postoperative Analgesia in Laparoscopic Gynecologic Surgeries: a Double-blind Randomized Controlled Trial.
Study Start Date : January 2010
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine


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
Drug: Ketorolac
Patients received intravenous injection of ketorolac (30 mg) in bolus; then, saline solution was continuously infused during the entire procedure (Group K),
Other Name: Toradol

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
Drug: Magnesium
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 Name: Magnesium sulfate

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).
Drug: Saline solution
intravenous saline solution (20 ml) was injected in bolus, followed by continuous infusion of saline solution during the entire procedure (Group S).
Other Name: Sodium chloride




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. time to first morphine rescue [ Time Frame: first 6 hours ]
    Time (in minutes) to the first dose of morphine

  2. morphine consumption [ Time Frame: 60 minutes ]
    total consumption of morphine in PACU



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02508857


Locations
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Brazil
Angela Maria Sousa
Sao Paulo, São Paulo, Brazil, 01403010
Sponsors and Collaborators
Instituto do Cancer do Estado de São Paulo
Investigators
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Principal Investigator: angela m sousa, phD Cancer Institute of the State of Sao Paulo
Publications of Results:
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Responsible Party: Instituto do Cancer do Estado de São Paulo
ClinicalTrials.gov Identifier: NCT02508857    
Other Study ID Numbers: NP0792010
First Posted: July 27, 2015    Key Record Dates
Last Update Posted: July 27, 2015
Last Verified: July 2015
Keywords provided by Instituto do Cancer do Estado de São Paulo:
pain, postoperative
anesthesia adjuvants
magnesium sulfate
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Ketorolac
Magnesium Sulfate
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Tocolytic Agents
Reproductive Control Agents