Ketamine Versus Magnesium Sulfate in the Time and Awakening Quality of General Anesthesia.
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| ClinicalTrials.gov Identifier: NCT04360473 |
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Recruitment Status :
Recruiting
First Posted : April 24, 2020
Last Update Posted : March 29, 2022
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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.
| Condition or disease | Intervention/treatment | Phase |
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| Awakening, Post-Anesthesia Delayed | Other: General anesthesia Drug: Ketamine plus general anesthesia Drug: Magnesium sulfate plus general anesthesia Drug: ketamine plus magnesium sulfate plus general anesthesia | Not Applicable |
Intervention: the sample of participants will be distributed in 4 groups. The placebo (PG) group will receive 100 ml of saline solution 15 min before anesthetic induction. The ketamine group (KG) will receive 0.3 mg / kg of ketamine in saline (total volume of 100 ml) 15 min before anesthetic induction. The magnesium sulfate group (SG) will receive 40 mg / kg of magnesium sulfate in saline solution (total volume of 100 ml) 15 min before anesthetic induction. The mixed group (MG) 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 anesthetic induction. All participants will be submitted to balanced anesthesia. Anesthetic induction will be started after 5 min of pre-oxygenation, with lidocaine 1.5 mg / kg, fentanyl 3 µg / kg, propofol until clinical hypnosis, cisatracurium 0.1 mg / kg and intubation after adequate neuromuscular relaxation. Maintenance will be with sevoflurane in concentration under clinical demand, repeating boluses of fentanyl 1 µg / kg and cisatracurium 0.03 mg / kg, as needed.
Primary Outcomes: time between the end of anesthetic administration and bispectral index (BIS) > 60, and a battery of neuropsychological tests to assess postoperative cognitive dysfunction tested in the Brazilian population 3 h after the end of anesthetic administration.
Secondary Outcomes: response to the brief pain inventory questionnaire and opioid consumption in the first 2 postoperative days.
Recruitment and timeline : patients will be recruited in the pre-anesthetic evaluation and assessments will be made of covertly in the immediate postoperative period and during the two days after surgery, being registered the pain scores and the consumption of opioids.
Sample calculation: the sample of 120 participants was calculated with a 95% confidence index and 80% statistical power. To compensate for losses, 140 individuals will be recruited.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 140 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | This is a prospective, controlled, covered and randomly distributed trial |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Masking Description: | 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. |
| Primary Purpose: | Treatment |
| Official Title: | Ketamine Versus Magnesium Sulfate in the Time and Awakening Quality of General Anesthesia. Randomized Clinical Study. |
| Actual Study Start Date : | March 14, 2022 |
| Estimated Primary Completion Date : | December 2022 |
| Estimated Study Completion Date : | December 2022 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Control group
The patients in this group will receive general balanced anesthesia
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Other: General anesthesia
Balanced general anesthesia. Induction with lidocaine, fentanyl, propofol and cisatracurium. Maintenance with sevoflurane.
Other Name: Control group |
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Experimental: Ketamine group
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
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Drug: Ketamine plus general anesthesia
ketamine 0.3 mg / kg 15 minutes before balanced general anesthesia. Induction with lidocaine, fentanyl, propofol and cisatracurium. Maintenance with sevoflurane.
Other Name: Ketamine group |
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Experimental: Magnesium sulfate group
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
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Drug: Magnesium sulfate plus general anesthesia
Magnesium sulfate 40 mg / kg 15 minutes before balanced general anesthesia. Induction with lidocaine, fentanyl, propofol and cisatracurium. Maintenance with sevoflurane.
Other Name: Magnesium sulfate group |
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Experimental: Magnesium / ketamine group
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
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Drug: ketamine plus magnesium sulfate plus general anesthesia
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
Other Name: Magnesium / ketamine group |
- Time for awakening [ Time Frame: Three hours ]Time, after the end of anesthetic administration, to get the bispectral index (BIS) > 60.
- Awakening quality [ Time Frame: Three hours ]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.
- Postoperative pain [ Time Frame: Two days ]Verbal pain score 0 (without pain) to 10 (worst imaginable pain), and the effect of pain over humor, ambulation and sleep, each one 0 (without effect) to 10 (worst imaginable effect)
- Postoperative analgesia [ Time Frame: Two days ]Opioid consumption
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- patients scheduled to undergo laparoscopic cholecystectomy, agreement to voluntarily participate in the trial and sign the free and informed consent form.
Exclusion Criteria:
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04360473
| Contact: sebastião ernesto | 12991457764 | sebasernesto@gmail.com |
| Brazil | |
| Hospital da Beneficência Portuguesa de Santos | Recruiting |
| Santos, São Paulo, Brazil, 11065910 | |
| Contact: joaquim vieira, MD 55-11-30618716 joaquimve@usp.br | |
| Contact: Sebastião Silva Filho, Physician 12991457764 sebasernesto@gmail.com | |
| Principal Investigator: | Joaquim Vieira | University of Sao Paulo School of Medicine |
| Responsible Party: | Joaquim Edson Vieira, Associate professor, University of Sao Paulo General Hospital |
| ClinicalTrials.gov Identifier: | NCT04360473 |
| Other Study ID Numbers: |
CAAE 28762619.0.0000.5448 |
| First Posted: | April 24, 2020 Key Record Dates |
| Last Update Posted: | March 29, 2022 |
| Last Verified: | March 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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postoperative awakening general anesthesia magnesium sulfate ketamine |
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Delayed Emergence from Anesthesia Postoperative Complications Pathologic Processes Magnesium Sulfate Ketamine Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Anesthetics, Dissociative Anesthetics, Intravenous |
Anesthetics, General Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anti-Arrhythmia Agents Anticonvulsants Calcium Channel Blockers Membrane Transport Modulators Calcium-Regulating Hormones and Agents Tocolytic Agents Reproductive Control Agents |