Magnesium Sulfate on Postoperative Pain

NCT ID: NCT05880732

Last Updated: 2023-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2022-03-01

Brief Summary

Breast cancer is the most diagnosed type of cancer in women in Turkey and in the world. According to the World Health Organization data, the rate of newly diagnosed breast cancer was reported as 11.6% in 20181. Acute postoperative pain occurs in 40% of patients undergoing surgery for breast cancer2. In the early postoperative period, opioids are commonly used analgesics in the treatment of pain, but they have various side effects such as gastrointestinal, urinary and respiratory symptoms3. Non-opioid analgesics can be used to reduce opioid use and thus limit its side effects. Magnesium sulfate (MgSO4) is an N-Methyl D-Aspartate (NMDA) receptor antagonist that has been used for postoperative analgesia and reducing both the duration and intensity of pain by preventing central sensitization in response to peripheral painful stimulus4-9. The primary aim of this study is to investigate the postoperative analgesic efficacy of MgSO4 in patients who were scheduled for mastectomy with the diagnosis of breast cancer. The secondary aim of our study is to evaluate the changes in perioperative vital signs that may occur due to MgSO4.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Group I

The study group (Group I) was given 50 mg/kg MgSO4 in 250 ml of isotonic 30 minutes before induction,

Group Type: EXPERIMENTAL

Magnesium Sulfate

Intervention Type: DRUG

Magnesium sulfate (MgSO4) is an N-Methyl D-Aspartate (NMDA) receptor antagonist that has been used for postoperative analgesia and reducing both the duration and intensity of pain by preventing central sensitization in response to peripheral painful stimulus4-9.

Group II

the control group (Group II) was given only 250 ml of normal saline isotonic solution 30 minutes before induction,

Group Type: PLACEBO_COMPARATOR

normal saline isotonic solution

Intervention Type: DRUG

only 250 ml of normal saline isotonic solution 30 minutes before induction,

Interventions

Magnesium Sulfate

Magnesium sulfate (MgSO4) is an N-Methyl D-Aspartate (NMDA) receptor antagonist that has been used for postoperative analgesia and reducing both the duration and intensity of pain by preventing central sensitization in response to peripheral painful stimulus4-9.

Intervention Type: DRUG

normal saline isotonic solution

only 250 ml of normal saline isotonic solution 30 minutes before induction,

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Female breast cancer patients scheduled for mastectomy and modified radical mastectomy

2. 18≥ years and

3. Patients with ASA score I-II

Exclusion Criteria

1. The patient who refused the study

2. Drug allergy

3. Unregulated diabetes mellitus and hypertension

4. Cardiac failure with <45% ejection fraction

5. Renal failure (serum creatinine > 2 mg/dL)

6. Liver failure (blood transaminase values 2 fold higher than normal)

7. Glaucoma

8. Psychiatric or neurological disorders

9. Communication difficulties with patient

10. Calcium channel blockers or narcotic drugs uses before surgery

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Pamukkale University

OTHER

Sponsor Role: lead

Responsible Party

Ilknur Hatice Akbudak, MD

assistant professor doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Pamukkale Univercity Medical School

Denizli, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

PAU123

Identifier Type: -

Identifier Source: org_study_id