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Effects of Intraoperative Magnesium Sulfate on Perioperative Pain Relief After Spine Surgery

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ClinicalTrials.gov Identifier: NCT04161729
Recruitment Status : Completed
First Posted : November 13, 2019
Last Update Posted : May 14, 2020
Sponsor:
Information provided by (Responsible Party):
Georgia Tsaousi, Aristotle University Of Thessaloniki

Tracking Information
First Submitted Date  ICMJE November 3, 2019
First Posted Date  ICMJE November 13, 2019
Last Update Posted Date May 14, 2020
Actual Study Start Date  ICMJE January 28, 2020
Actual Primary Completion Date May 3, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 12, 2019)
Analgesics consumption postoperatively in morphine equivalents [ Time Frame: 24 hours after the emergence from anesthesia ]
The difference in analgesic consumption (assessed as mg of morphine equivalents) postoperatively after intravenous infusion of magnesium sulfate or isotonic saline 0.9%
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 12, 2019)
  • Analgesics consumption intraoperatively [ Time Frame: 180 minutes intraoperatively ]
    The difference in analgesics consumption (μg of remifentanil) intraoperatively after /during intravenous infusion of magnesium sulfate or isotonic saline 0.9%
  • Pain intensity [ Time Frame: 10 minutes after emergence from anesthesia, 2, 4 and 6 hours after the emergence from anesthesia ]
    The difference in pain intensity postoperatively assessed by Visual Analogue Scale, Numerical Pain Scale or Verbal Pain Scale after intravenous infusion of magnesium sulfate or isotonic saline 0.9%
  • Time to first analgesic request in minutes [ Time Frame: 24 hours after the emergence from anesthesia ]
    The difference in the time frame (minutes) for analgesia request after emergence from anesthesia after intravenous infusion of magnesium sulfate or isotonic saline 0.9%
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 12, 2019)
  • Heart rate changes intraoperatively [ Time Frame: 180 minutes intraoperatively ]
    The changes in heart rate (beats per minute) intraoperatively after /during intravenous infusion of magnesium sulfate or isotonic saline 0.9%
  • Systemic blood pressure changes intraoperatively [ Time Frame: 180 minutes intraoperatively ]
    The changes in systemic blood pressure (mmHg) intraoperatively after /during intravenous infusion of magnesium sulfate or isotonic saline 0.9%
  • Postoperative adverse effects [ Time Frame: 24 hours after the emergence from anesthesia ]
    The incidence of shivering and nausea /vomiting after emergence from anesthesia after intravenous infusion of magnesium sulfate or isotonic saline 0.9%
  • Patients' satisfaction [ Time Frame: 24 hours after surgery ]
    The patients' global satisfaction assessed the day after surgery using a 5-grade scale (1= worst and 5= totally satisfied) after intravenous infusion of magnesium sulfate or isotonic saline 0.9%
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Effects of Intraoperative Magnesium Sulfate on Perioperative Pain Relief After Spine Surgery
Official Title  ICMJE Effects of Intraoperative Magnesium Sulfate on Pain Relief, Hemodynamics and Quality of Recovery After Spine Surgery
Brief Summary

The treatment of postoperative pain is increasingly based on a multimodal approach and although opioids remain the drug of choice, they are often used in combination with other analgesics (paracetamol, cyclooxygenase inhibitors or non-steroidal anti-inflammatory drugs) and co-analgesic agents (clonidine and anti- NMDA such as ketamine or MgSO4). The rationale for combined analgesia is to achieve additive or synergistic analgesic properties while decreasing the incidence of side effects by reducing the dose of each agent. Nociceptive stimuli are known to activate the release of the excitatory amino acid glutamate in the dorsal horn of the spinal cord. The resultant activation of NMDA receptors causes calcium entry into the cell and triggers central sensitisation. This mechanism is involved in the perception of pain and mainly accounts for its persistence during the postoperative period.

Although magnesium is not a primary analgesic in itself, it enhances the analgesic actions of more established analgesics as an adjuvant agent. Magnesium produces a voltage-dependent block of NMDA receptors and has been reported to have analgesic properties that might be related to this inhibiting property. Magnesium sulfate has been reported to be effective in perioperative pain treatment and in blunting somatic, autonomic and endocrine reflexes provoked by noxious stimuli.

When magnesium was used intraoperatively, many researchers reported that it reduced the requirement for anesthetics and/or muscle relaxants.

Intraoperative use of magnesium sulfate can also be associated with decreased incidences of nausea and vomiting after surgery, which could have been due to the lower consumption of anesthetics (i.e. volatile agents), rather than any antiemetic effect of magnesium sulfate. In addition, perioperative i.v. administration of magnesium sulfate has another advantageous effect, as it decreases the incidence of shivering by up to 70-90%. Previous studies investigating the analgesic efficacy of MgSO4 in general, gynaecological, ophthalmic and orthopaedic surgery have shown conflicting results, while reports regarding spine surgery are extremely limited.

Our study was designed to investigate the effects of MgSO4 on perioperative pain relief and postoperative quality of recovery after lumbar laminectomy surgery.

Detailed Description

Each participant will receive standard monitoring (ECG, SpO2, capnography, SBP, oesophageal temperature, accelerography) and an intravenous access will be established. The level of anaesthesia will be monitored with the bispectral index (BIS), targeting to a BIS level 40-50.

Group M patients will receive intravenous magnesium sulfate 20 mg/kg over a 15-min period before induction of anaesthesia and 20 mg/kg/h by continuous i.v. infusion during the operation. Group C will be given isotonic solution of 0.9% in the same volume as the study drug.

A standard anesthesia protocol will be applied involving propofol 2mg/kg (iv) and fendanyl 2 μg/kg (iv). Cis-atracurium 0.2 mg/kg (iv) will be given to facilitate endotracheal intubation. Anaesthesia will be maintained with air 50% and oxygen 50%, and desflurane adjusted to achieve a target BIS between 40 and 50. Remifentanil will be added to the anesthesia regimen as needed.

Hemodynamic parameters will be recorded upon

  • Baseline: Before the administration of the tested drug
  • T5: 5 minutes after the administration of the tested drug
  • T10: 10 minutes after the administration of the tested drug
  • T15: 15 minutes after the administration of the tested drug
  • Ts: surgical incision
  • T30: 30 minutes after the administration of the tested drug
  • T45: 45 minutes after the administration of the tested drug
  • T60: 60 minutes after the administration of the tested drug
  • T90: 90 minutes after the administration of the tested drug
  • T120: 120 minutes after the administration of the tested drug
  • T180: 180 minutes after the administration of the tested drug

Low arterial blood pressure during surgery defined as a mean blood pressure value < 50 mmHg will be treated by a bolus of 5 mg ephedrine administered intravenously or phenylephirne civ for persistent hypotension.

Also, time to accelerography recording indicating the appropriateness of neuromuscular block for intubation, mean expired desflurane concentration (from 30 min after skin incision to the end of surgery), boluses of ephedrine and total intraoperative remifentanil consumption will be recorded.

Postoperative analgesic protocol will involve paracetamol 1 mg (iv), lornoxicam 8mg (iv) and morphine 3 mg (upon request).

Postoperatively pain assessment will be performed by Visual Analogue Scale (VAS), Verbal Rating Scale (VRS) and Numerical Rating Scale (NRS) at emergence from anesthesia and 2, 4, 6, and 24 h in the study period. Time to first analgesic request and total analgesics consumption postoperatively (morphine equivalents) will be recorded. Episodes of shivering, as well as episodes of nausea and vomiting (PONV), will be recorded at emergence and thereafter, throughout the study period. Finally, patients' global satisfaction will be assessed the first day after surgery using a 5-grade scale (1= worst discomfort ever experienced in their life and 5= totally satisfied during the immediate postoperative period).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Analgesia
  • Pain, Postoperative
  • Spine Disease
Intervention  ICMJE
  • Drug: Magnesium Sulfate
    Intravenous magnesium sulfate 20 mg/kg in 100ml isotonic saline 0.9% over a 15-min period before induction of anesthesia and 20 mg/kg/h by continuous i.v. infusion until surgery completion.
  • Drug: Isotonic saline 0.9%
    Isotonic saline 0.9% 100ml over a 15-min period before induction of anesthesia and thereafter continuous i.v. infusion until surgery completion in dosage identical to magnesium sulfate group.
Study Arms  ICMJE
  • Active Comparator: Magnesium sulfate
    Magnesium sulfate 20 mg/kg intravenous over a 15-min period before induction of anesthesia and 20 mg/kg/h by continuous i.v. infusion until surgery completion.
    Interventions:
    • Drug: Magnesium Sulfate
    • Drug: Isotonic saline 0.9%
  • Placebo Comparator: Isotonic solution 0.9%
    Isotonic solution 0.9% in the same volume as the study drug using identical pattern of administration.
    Interventions:
    • Drug: Magnesium Sulfate
    • Drug: Isotonic saline 0.9%
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 13, 2020)
74
Original Estimated Enrollment  ICMJE
 (submitted: November 12, 2019)
66
Actual Study Completion Date  ICMJE May 5, 2020
Actual Primary Completion Date May 3, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adult patients aged between 18 and 80 years
  • ASA Physical status 1 to 3
  • Elective or semi-elective lumbar laminectomy surgery
  • Signed informed consent

Exclusion Criteria:

  • Under medication with calcium channel blockers or magnesium
  • Drugs or alcohol abuse
  • Neurological disorders
  • Myopathy
  • Intracardiac block
  • Hepatic failure
  • Renal failure
  • Pregnancy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Greece
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04161729
Other Study ID Numbers  ICMJE SpiMag
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Georgia Tsaousi, Aristotle University Of Thessaloniki
Study Sponsor  ICMJE Aristotle University Of Thessaloniki
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Georgia Tsaousi Aristotle University Of Thessaloniki
PRS Account Aristotle University Of Thessaloniki
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP