Lidocaine Compared to Magnesium Sulfate to Prolong Spinal Anesthesia: Non-inferiority Randomized Clinical Trial
Keywords
Abstract
Description
Both lidocaine and magnesium sulfate have been shown to prolong spinal anesthesia.
The number of studies using magnesium sulfate to improve spinal anesthesia is greater than the number of studies using lidocaine, and methodology varies significantly between studies.
Adverse effects of lidocaine are different from magnesium sulfate's. Lidocaine has a wider therapeutic interval with fewer side effects, including: Drowsiness, Feeling Anxious, Feeling Cold, Nervous, Numbness And Tingling, Signs And Symptoms At Injection Site, Twitching.
Magnesium sulfate's side effects include: heart disturbances, breathing difficulties, poor reflexes, confusion, weakness, flushing (warmth, redness, or tingly feeling), sweating, lowered blood pressure, feeling like you might pass out, anxiety, cold feeling, extreme drowsiness, muscle tightness or contraction, or headache.
Dates
| Last Verified: | 01/31/2020 |
| First Submitted: | 10/26/2018 |
| Estimated Enrollment Submitted: | 10/26/2018 |
| First Posted: | 10/29/2018 |
| Last Update Submitted: | 02/25/2020 |
| Last Update Posted: | 02/26/2020 |
| Actual Study Start Date: | 11/06/2018 |
| Estimated Primary Completion Date: | 01/31/2019 |
| Estimated Study Completion Date: | 03/31/2019 |
Condition or disease
Intervention/treatment
Drug: Magnesium Sulfate
Drug: Lidocaine
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: Magnesium Sulfate Continuous intravenous infusion of 15mg/kg/h of magnesium sulfate, starting just after spinal anesthesia infusion until the end of surgery | Drug: Magnesium Sulfate Magnesium Sulfate 15mg/kg/h |
| Experimental: Lidocaine Continuous intravenous infusion of 1.5mg/kg/h of lidocaine, starting just after spinal anesthesia infusion until the end of surgery | Drug: Lidocaine Lidocaine 1,5mg/kg/h |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: - Will receive spinal anesthesia for TURP por Histerectomy Exclusion Criteria: - Protocol violation; - Severe adverse events; - Change to general anesthesia or addition of epidural anesthesia; - Complete or partial spinal block failure; - Mental status alteration (agitation, confusion, loss of conciousness). |
Outcome
Primary Outcome Measures
1. Sensitive block duration [9 hours]
Secondary Outcome Measures
1. Motor block duration [9 hours]
2. Two levels regression [9 hours]
3. Pain at postanesthesia care unit [1-3 hours]
