Clinical trial

The Effect of Intravenous Magnesium Sulfate Use on Intraoperative Remifentanil Consumption and Postoperative Pain in Laparoscopic Hysterectomy Cases

Name

drilke

Description

In our study, it was aimed to show the contribution of intraoperative intravenous magnesium sulfate administration to peroperative opioid consumption and postoperative analgesia.

Trial arms

Trial start

2024-01-20

Estimated PCD

2024-03-30

Trial end

2024-06-15

Status

Recruiting

Treatment

magnesium sulfate group

Anesthesia induction was provided with propofol (2mg/kg), fentanyl (2mcg/kg). Intubation was performed after administration of 0.6 mg/kg rocuronium with an appropriate endotracheal tube. Anesthesia was maintained using AIR/O2 (50%/50%), 1 minimum alveolar concentration (MAC) sevoflurane, 0.1-0.25 mcg/kg/min remifentanil infusion. The target BIS value was kept between 40 and 50. Systolic blood pressure (SBP) \<90mmHg or \<20% of baseline was considered hypotension; remifentanil infusion was reduced. If no response was obtained, 5-10 mg of IV ephedrine was administered. HR \< 45 beats/min was evaluated as bradycardia; IV atropine 0.5 mg was planned The magnesium group received a bolus of 20 mg/kg of magnesium sulfate in 100 mL of saline for 15 minutes prior to induction, followed by a continuous infusion of 20 mg/kg/hr until skin closure.

Arms:

Magnesium sulfate

Other names:

magnesium sulfate

Placebo

Anesthesia induction was provided with propofol (2mg/kg), fentanyl (2mcg/kg). Intubation was performed after administration of 0.6 mg/kg rocuronium with an appropriate endotracheal tube. Anesthesia was maintained using AIR/O2 (50%/50%), 1 minimum alveolar concentration (MAC) sevoflurane, 0.1-0.25 mcg/kg/min remifentanil infusion. The target BIS value was kept between 40 and 50. Systolic blood pressure (SBP) \<90mmHg or \<20% of baseline was considered hypotension; remifentanil infusion was reduced. If no response was obtained, 5-10 mg of IV ephedrine was administered. HR \< 45 beats/min was evaluated as bradycardia; IV atropine 0.5 mg was planned The same volume of isotonic saline for the control group was administered as indicated in the magnesium group.

Arms:

Placebo

Other names:

saline

Size

Primary endpoint

Fentanyl consumption in the first 24 hours after surgery

Postoperative Day 1

Eligibility criteria

Inclusion Criteria: * Patient undergoing abdominal hysterectomy * Between the ages of 20-70, * ASA I- II Exclusion Criteria: * Presence of hepatic and renal dysfunction, * Presence of cardiac arrhythmia or other cardiac comorbidity, * Neurological and psychiatric disorder, * Chronic use of calcium and beta blockers, * Drug or alcohol abuse, * Pregnancy and lactation status, * Patients with a history of allergy to any drug included in the study protocol

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The patients were randomly divided into two groups according to a 1:1 randomization ratio using opaque sealed envelopes before surgery. Study randomization was performed using computer generated randomization codes by SPSS v23.0 (IBM, New York, USA). Each patient was asked to choose an envelope and the patients were assigned to the study according to the group specified in the envelope. The drugs to be used were prepared 30 minutes before the surgery by the nurse who did not participate in the study in the drug preparation room. Everyone involved in this study, including patients, researchers, the anesthesiologist responsible for anesthesia management, and the surgeon, remained blind to group distribution during the study.', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}

Updated at

2024-05-08

1 organization

1 product

1 drug

3 indications

Organization

Ondokuz Mayıs University

Product

Magnesium Sulfate

Indication

Laparoscopic Hysterectomy

Indication

Magnesium sulfate

Indication

General Anesthesia

Drug

Varlilumab