Ketamine Versus Magnesium Sulfate in the Time and Awakening Quality of General Anesthesia.

NCT04360473 | Recruiting DMC

• 1 other identifier: CAAE 28762619.0.0000.5448
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

The introduction of the laparoscopic technique for cholecystectomy significantly reduced the incidence and intensity of postoperative pain, with improvement in other markers, such as patient satisfaction, and reduction in hospital stay. However, pain in the postoperative period of laparoscopic cholecystectomy is still a concern that challenges modern anesthesiology. Ketamine and magnesium sulfate are two blockers of N-methyl-D-aspartate (NMDA) receptors with the ability to reduce postoperative pain and postoperative opioid consumption. A frequent concern among anesthesiologists is the quality and time of awakening in patients receiving these medications The main objective of this trial is to compare the quality and time of awakening in patients receiving magnesium sulfate or ketamine. The secondary objective is to compare postoperative analgesia during the postoperative hospital stay. Hypothesis: Our hypothesis is that patients have a faster awakening when they receive magnesium sulfate as an analgesic adjunct, when compared to patients who receive ketamine . Design: this is a prospective, controlled, covered and randomly distributed trial.

Conditions

Awakening, Post-Anesthesia Delayed

Keywords

postoperative awakening; general anesthesia; magnesium sulfate; ketamine

Outcome Measures

Primary Outcomes (2)

• Time for awakening

  Time, after the end of anesthetic administration, to get the bispectral index (BIS) \> 60.

  Three hours

• Awakening quality

  Questions related to name, place, time, reason for hospitalization and verbal learning test, consisting of 15 words that the patient will be asked to repeat 20 minutes after hearing them. The wrong answers will be compared among groups.

  Three hours

Secondary Outcomes (2)

• Postoperative pain

  Two days

• Postoperative analgesia

  Two days

Study Arms (4)

Control group

ACTIVE COMPARATOR

The patients in this group will receive general balanced anesthesia

Other: General anesthesia

Ketamine group

EXPERIMENTAL

The patients in this group will receive 0.3 mg / kg of ketamine in saline (total volume of 100 ml) 15 min before general balanced anesthetic induction

Drug: Ketamine plus general anesthesia

Magnesium sulfate group

EXPERIMENTAL

The patients in this group will receive 40 mg / kg of magnesium sulfate in saline solution (total volume of 100 ml) 15 min before general balanced anesthetic induction

Drug: Magnesium sulfate plus general anesthesia

Magnesium / ketamine group

EXPERIMENTAL

The patients in this group will receive 0.15 mg / kg of ketamine + 20 mg / kg of magnesium sulfate in saline solution (total volume of 100 ml) 15 min before general balanced anesthetic induction

Drug: ketamine plus magnesium sulfate plus general anesthesia

Interventions

General anesthesia OTHER

Balanced general anesthesia. Induction with lidocaine, fentanyl, propofol and cisatracurium. Maintenance with sevoflurane.

Also known as: Control group

Control group

Ketamine plus general anesthesia DRUG

ketamine 0.3 mg / kg 15 minutes before balanced general anesthesia. Induction with lidocaine, fentanyl, propofol and cisatracurium. Maintenance with sevoflurane.

Also known as: Ketamine group

Ketamine group

Magnesium sulfate plus general anesthesia DRUG

Magnesium sulfate 40 mg / kg 15 minutes before balanced general anesthesia. Induction with lidocaine, fentanyl, propofol and cisatracurium. Maintenance with sevoflurane.

Also known as: Magnesium sulfate group

Magnesium sulfate group

ketamine plus magnesium sulfate plus general anesthesia DRUG

Ketamine 0.15 mg/kg plus magnesium sulfate 20 mg/kg 15 minutes before balanced general anesthesia. Induction with lidocaine, fentanyl, propofol and cisatracurium. Maintenance with sevoflurane

Also known as: Magnesium / ketamine group

Magnesium / ketamine group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients scheduled to undergo laparoscopic cholecystectomy, agreement to voluntarily participate in the trial and sign the free and informed consent form.

You may not qualify if:

• Coronary disease, ventricular atrial block II or worse, with renal failure , previous history of brain disease, dementia or other psychiatric diseases, and patients with a body mass index\> 35 kg / m² , allergy to any products used in the trial, preoperative use of opioids or corticosteroids.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Hospital da Beneficência Portuguesa de Santos

Santos, São Paulo, 11065910, Brazil

RECRUITING

Related Publications (1)

• REFERENCES 1. Hendolin HI, Pääkkönen ME, Alhava EM, Tarvainen R, Kemppinen T, Lahtinen. Laparoscopic or open cholecystectomy: a prospective randomized trial to compare postoperative pain, pulmonary function, and stress response. Eur J Surg. 2000; 166: 394-9. 2. Attwood SEA, Hill ADK, Mealy K, Stephens RB. A prospective comparison of laparoscopic versus open cholecystectomy. Annlas of the Royal College of Surgeons of England. 1992; 74: 397-400. 3. Keus F, by Jong J, Gooszen HG, Laarhoven CJHM. Laparoscopic versus open cholecystectomy for patients with symptomatic cholecystolithiasis. Cochrane Database of Systematic Reviews. 2006, Issue 4. Art. No.: CD006231. 4. Barazanchi AWH, MacFater WS, Rahiri JL, Tutone S, Hill AG, Joshi GP. Evidence-based management of pain after laparoscopic cholecystectomy: a PROSPECT review update. Br J Anaesth. 2018; 121: 787-803. 5. Bisgaard T, Klarskov B, Rosenberg J, Kehlet H. Characteristics and prediction of early pain after laparoscopic cholecystectomy. Pain. 2001 ; 90: 261-9. 6. Ye Fan, Wu Y, Zhou C. Effect of intravenous ketamine for postoperative analgesia in patients undergoing laparoscopic cholecystectomy. Meta-analysis. Medicine. 2017; 96: 51 7. Launo C, Bassi C, Spagnolo L, Badano S, Ricci C, Lizzi A, et al. Preemptive ketamine during general anesthesia for postoperative analgesia in patients undergoing laparoscopic cholecystectomy. Minerva Anestesiol. 2004; 70: 727-38. 8. Hang LH, Shao DH, Gu YP. The ED50 and ED95 of ketamine for prevention of postoperative hyperalgesia after remifentanil-based anesthesia in patients undergoing laparoscopic cholecystectomy. Swiss Med Wkly. 2011; 141: w13195 . 9. Minds O, Harlak A, Yigit T, Balkan A, Balkan M, Cosar A, et al. Effect of intraoperative magnesium sulphate infusion on pain relief after laparoscopic cholecystectomy. Acta Anaesthesiol Scand. 2008; 52: 1353-9. 10. 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: 349-53. 11. Valentin LSS, Pietrobon R, Junior WA, et al. Definition and application of a battery of neuropsychological tests to assess postoperative cognitive dysfunction. Einstein. 2015; 13: 20-6.

  BACKGROUND

MeSH Terms

Conditions

Delayed Emergence from Anesthesia

Interventions

Anesthesia, General; Control Groups; Ketamine; Magnesium Sulfate; Magnesium

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Metals, Alkaline Earth; Elements; Metals, Light; Metals

Study Officials

• Joaquim Vieira

  University of Sao Paulo School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

sebastião ernesto

CONTACT

12991457764; sebasernesto@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The person responsible for generating the sequence will use the result of the lottery to number the opaque envelopes and place the intervention corresponding to the group to which that lottery number belongs. This professional will not administer anesthesia to the patients in the study and will not participate in the collection or evaluation of the studied variables. The envelopes will be opened by professionals who will prepare the corresponding solution, keeping this information covered for the other members of the team and for the patients. The groups will be covered up for patients and for professionals who carry out the assessments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: This is a prospective, controlled, covered and randomly distributed trial

Study Record Dates

• First Submitted: April 18, 2020
• First Posted: April 24, 2020
• Study Start: March 14, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 8, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)