Effect of Intraoperative Magnesium Infusion on Postoperative Pain and Cognitive Function

February 3, 2020 updated by: Samaa Rashwan, Beni-Suef University

Effect of Intraoperative Magnesium Infusion on Postoperative Pain and Cognitive Function After Pelvi-abdominal Surgeries :an Observational Study

The aimof this study is to observe the effect of intraoperative magnesium infusion on peri-operative pain and postoperative cognitive functions in adult patients after elective pelvi-abdominal surgeries.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This study will be conducted at Beni-Suef University Hospital after approval of the anesthesiology, surgical ICU and pain management department, and the local ethics and research committee, and obtaining written informed consents from the patients .

The inclusion criteria:

  1. Male and female patients (age 20-60 years)
  2. American Society of Anesthesiology(ASA) physical status I-II
  3. Patients scheduled for elective pelvi-abdominal surgeries

The Exclusion criteria

  1. Patients having significant cardiovascular (cardiomyopathy or moderate to severe valvular heart lesion) , significant hepatic disease (Child-Pugh score B or C ), renal or CNS disease
  2. Patients with uncontrolled hypertension or diabetes
  3. History of hypersensitivity to the drugs to be used
  4. Control MMSE score ≤23
  5. Women who are pregnant or breastfeeding
  6. Patients taking Ca2+ channel blockers, opioids, antidepressants, or antipsychotics or alcohol
  7. Patients having difficulty understanding , vision or hearing problems or CNS disorder as parkinson's disease .
  8. Morbidly obese patients with a body mass index of >40
  9. Patients who refused to be involved within the scope of the research. Management of the patients in the operation room All patients will be informed about the tests and written informed consent will be obtained from each of them. The MMSE will be applied. After arrival to the operation theater the monitors will be applied including will be applied including 5 leads ECG, non invasive arterial blood pressure and pulse oximetry. Urinary catheter will be inserted for urine output monitoring. Train of four (TOF) monitoring and Bispectral index (BIS) monitoring will be done in order to evaluate the depth of hypnosis (A-2000 Bispectral Index, Aspect Medical Systems, the Netherlands).

Following 100% oxygen of 5 L/min for 3 min, 1% lidocaine at 0.5 mg/kg will be given intravenously in order to prevent potential injection pain due to propofol and to suppress hemodynamic response to endotracheal intubation. Propofol 2 mg/kg, midazolam 0.03 mg/kg, fentanyl 3μg/kg and 0.6 mg /kg atracurium will be given followed by intubation and Mechanical ventilation with 6 mL/kg tidal volume and a frequency of 8-12/min with total of 4 L/min in 40% O2 air mixture to keep EtCO2 between 36 and 40 mmHg. Anesthesia will be maintained using oxygen and 1-1.5 minimum alveolar concentration (MAC) of isoflurane.

After the induction of anesthesia, a loading dose of magnesium sulfate 50mg/kg in 100mL of isotonic saline as within 5 to 10 minutes followed by a maintenance dose of 10 mg/kg/hr up to the end of surgery .24 In case of a patient with hypotension (mean arterial pressure ˂55 mmHg), 5 mg ephedrine will be injected so that the mean arterial pressure could reach higher than 55 mm Hg. If arrhythmia occured in any of the patients during operation, proper treatment will be be performed and the patient will be excluded from the study. The magnesium sulphate and anaesthetic agent infusions will be discontinued at skin closure. The relaxant effect of magnesium sulfate will be considered so train of four (TOF) monitoring will be used to monitor the muscle relaxation during the surgery and patients will be extubated at the end of the operation based on the TOF > 0.9 to ensure the complete reversal of relaxants by neostigmin.

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Banī Suwayf, Egypt, 6215
      • Giza, Egypt, 6125
        • Recruiting
        • Faculty of Medicine, Beni-SuefUniversity
        • Contact:
      • Giza, Egypt, : 62511
        • Recruiting
        • Faculty of Medicine,Beni-Suef University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male and female patients (age 20-60 years)
  2. American Society of Anesthesiology(ASA) physical status I-II
  3. Patients scheduled for elective pelvi-abdominal surgeries

Exclusion Criteria:

  1. Patients having significant cardiovascular (cardiomyopathy or moderate to severe valvular heart lesion) , significant hepatic disease (Child-Pugh score B or C ), renal or CNS disease
  2. Patients with uncontrolled hypertension or diabetes
  3. History of hypersensitivity to the drugs to be used
  4. Control MMSE score ≤23
  5. Women who are pregnant or breastfeeding
  6. Patients taking Ca2+ channel blockers, opioids, antidepressants, or antipsychotics or alcohol
  7. Patients having difficulty understanding , vision or hearing problems or CNS disorder as parkinson's disease .
  8. Morbidly obese patients with a body mass index of >40
  9. Patients who refused to be involved within the scope of the research.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: magnesium sulphate
After the induction of anesthesia, a loading dose of magnesium sulfate 50mg/kg in 100mL of isotonic saline as within 5 to 10 minutes followed by a maintenance dose of 10 mg/kg/hr up to the end of surgery
Drug: Magnesium Sulfate
After the induction of anesthesia, a loading dose of magnesium sulfate 50mg/kg in 100mL of isotonic saline as within 5 to 10 minutes(23) followed by a maintenance dose of 10 mg/kg/hr up to the end of surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
magnesium infusion on postoperative cognitive functions in adult patients after elective pelvi-abdominal surgeries.
Time Frame: the observation will be for 24 hours
After the induction of anesthesia, a loading dose of magnesium sulfate 50mg/kg in 100mL of isotonic saline as within 5 to 10 minutes(23) followed by a maintenance dose of 10 mg/kg/hr up to the end of surgery
the observation will be for 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beni-Suef University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 15, 2020

Primary Completion (Anticipated)

April 15, 2020

Study Completion (Anticipated)

April 15, 2020

Study Registration Dates

First Submitted

February 3, 2020

First Submitted That Met QC Criteria

February 3, 2020

First Posted (Actual)

February 5, 2020

Study Record Updates

Last Update Posted (Actual)

February 5, 2020

Last Update Submitted That Met QC Criteria

February 3, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • faculty of medicine Beni-Suef

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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