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Magnesium Sulfate Versus Dexmedetomidine on Anesthesia Awakening.

NCT04300985 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2023-01-11

No results posted yet for this study

Summary

Magnesium sulfate (MS) and dexmedetomidine have already demonstrated the ability to reduce intra and postoperative consumption of anesthetics and analgesics, among others advantages, such as blood pressure control and intraoperative bleeding. The MS has also been shown to be useful in pre-eclampsia and eclampsia control, pulmonary hypertension, asthma, cardiac arrhythmias and pheochromocytoma). Despite these advantages in the use of these important adjuncts, there is a concern about the quality and awakening time of the patients who use them. The purpose of this trial is to compare the time and quality of awakening in patients submitted to general anesthesia and receiving MS or dexmedetomidine as adjuncts in the intraoperative analgesia.

The main objective of this trial is to compare the quality and the awakening time in patients receiving MS or dexmedetomidine. The secondary objective is the comparison of postoperative analgesia in the postoperative hospitalization period. Hypothesis: Our hypothesis is that patients present a faster awakening when receive MS as an analgesic adjunct, when compared to patients who receive dexmedetomidine. Drawing: this is a prospective, controlled, covert trial with random distribution for noninferiority trialing.

Conditions

  • Cholecystectomy

Interventions

DRUG

Dexmedetomidine

Patients will start receiving dexmedetomidine 15 minutes before general anesthetic induction.

DRUG

Sham treatment

Patients will start receiving saline solution infusion 15 minutes before general anesthetic induction.

DRUG

Magnesium Sulfate

Patient will start receiving magnesium infusion (20 mg/kg/h) 15 minutes before general anesthetic induction.

Sponsors & Collaborators

  • University of Sao Paulo General Hospital

    lead OTHER

Principal Investigators

  • Sebastião Silva Filho · Hospital da Sociedade de Beneficência Portuguesa d

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2022-12-20
Completion
2022-12-20

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04300985 on ClinicalTrials.gov