Magnesium Sulfate Versus Dexmedetomidine on Anesthesia Awakening.

NCT04300985 | Completed Phase 3

• 1 other identifier: CAAE 28455419.9.0000.5448
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Time to awake from anesthesia between groups

  Comparing time in minutes to get bispectral index higher than 60 in both groups

  Three hours

Secondary Outcomes (1)

• Comparing postoperative analgesia between groups

  Two days

Study Arms (3)

Placebo group

SHAM COMPARATOR

Thirty patients in this group will receive infusion of 100 saline solution. After 15 min of beginning of this infusion they will start receiving general anesthesia administration.

Drug: Sham treatment

Dexmedetomidine group

ACTIVE COMPARATOR

Thirty patients in this group will receive infusion of dexmedetomidine (0,5 mcg/kg/min). After 15 min of the beginning of this infusion they will start in the general anesthesia induction.

Drug: Dexmedetomidine

Magnesium sulfate group

ACTIVE COMPARATOR

Thirty patients in this group will receive infusion of magnesium sulfate (20 mg/kg/h). After 15 min of the beginning of this infusion they will start in the general anesthesia induction.

Drug: Magnesium Sulfate

Interventions

Dexmedetomidine DRUG

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

Also known as: Dexmedetomidine and general anesthesia

Dexmedetomidine group

Sham treatment DRUG

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

Also known as: Saline solution and general anesthesia

Placebo group

Magnesium Sulfate DRUG

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

Also known as: Magnesium sulfate and general anesthesia

Magnesium sulfate group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for video laparoscopic cholecystectomy, between 18 and 70 years old, physical status I ou II in the American Society of Anesthesiology classification

You may not qualify if:

• Allergy or contraindication to the study protocol substances, refuse to participate or sign the informed consent, heart block \> atrioventricular I, renal failure, brain disease, dementia or other psychiatric diseases, body mass index \> 35 kg/m², Portuguese language limitations, preoperative use of opioid or corticosteroids.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Hospital das Clínicas - Faculdade de Medicina da Universidade de Sao Paulo

São Paulo, 01246-903, Brazil

Location

Related Publications (1)

• 1. Telci L, Esen F, Akcora D, Erden T, Canbolat AT, Akpir K. Evaluation of effects of magnesium sulfate in reducing intraoperative anaesthetic requirements. Br J Anaesth. 2002; 89: 594-598. 2. Chen C, Tao R. The impact of magnesium sulfate on pain control after laparoscopic cholecystectomy: a meta-analysis of randomized controlled studies. Surg Laparosc Endosc Percutan. 2018; 28: 349-353. 3. Andjelkovic L, Novak-Jankovic V, Pozar-Lukanovic N, Bosnic Z, Spindler-Vesel A. Influence of dexmedetomidine and lidocaine on perioperative opioid consumption in laparoscopic intrialine resection: a randomized controlled clinical trial. J Int Med Res. 2018; 46: 5143-5154.

  BACKGROUND

MeSH Terms

Interventions

Dexmedetomidine; Anesthesia, General; Saline Solution; Magnesium Sulfate

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anesthesia; Anesthesia and Analgesia; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Sebastião Silva Filho

  Hospital da Sociedade de Beneficência Portuguesa d

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: One professional of the team of providers will be responsible for conducting the electronic drawing on the website www.random.org, to distribute 90 numbers randomly into three groups. By following the results he or she will identify 90 opaque envelopes with numbers, and inside of each envelope will be a card with the name of corresponding group and the instructions about the corresponding intervention. This professional will not take part in any other part of the investigation. Every other professionals of the team and the patient will be blinded to group to which the patient belong. Each of the invited patient who accepts to participate and sign the consent form in the pre-anesthetic consultation, will receive the sequential envelope and be part of the corresponding group. At the arrival in the surgical center, one particular professional of the team will open the envelope and prepare the blinded solution, that will still be unclosed to any other people in the trial.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: This is a prospective, controlled, blinded trial with random distribution.

Study Record Dates

• First Submitted: February 29, 2020
• First Posted: March 9, 2020
• Study Start: October 1, 2021
• Primary Completion: December 20, 2022
• Study Completion: December 20, 2022
• Last Updated: January 11, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)