Neuromuscular Blockade Clinical Trial
Official title:
The Reversal of Residual Neuromuscular Blockade After Neostigmine and Half-dose Sugammadex: A Comparison With Standard Reversal of Full-dose Neostigmine
Verified date | September 2021 |
Source | Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Sugammadex may prevent residual neuromuscular blockade by providing rapid reversal at the end of the operation. Our goal is to compare the half-dose use of sugammadex for reversing residual blockade after administration of neostigmine and atropine to the routine use of reversal medication.
Status | Completed |
Enrollment | 113 |
Est. completion date | December 30, 2016 |
Est. primary completion date | October 1, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 65 Years |
Eligibility | Inclusion Criteria: - Inclusion criteria: - 40 and 65 years of age, - American Society of Anesthesiologists Physical Status (ASA-PS) of 3 and 4, - Elective lower gastrointestinal tumor resection surgeries, - Supine positioning, - Surgery requiring use of general anesthesia and muscle relaxation, - Use of inhalational agent of sevoflurane anesthesia, - Surgical duration of about three to six hours. Exclusion Criteria: - History of known or suspected neuromuscular disease, - History of renal or hepatic dysfunction, - Hyperkalemia, - Patients receiving antibiotics, anticonvulsants, or magnesium, - History of stroke, - History of glaucoma, - History of pregnancy or breastfeeding, - Suspicion of abdominal infection or sepsis, - Suspected history of malignant hyperthermia, - An allergy to medications used during general anesthesia |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital |
Aouad MT, Alfahel WS, Kaddoum RN, Siddik-Sayyid SM. Half dose sugammadex combined with neostigmine is non-inferior to full dose sugammadex for reversal of rocuronium-induced deep neuromuscular blockade: a cost-saving strategy. BMC Anesthesiol. 2017 Apr 11 — View Citation
Cheong SH, Ki S, Lee J, Lee JH, Kim MH, Hur D, Cho K, Lim SH, Lee KM, Kim YJ, Lee W. The combination of sugammadex and neostigmine can reduce the dosage of sugammadex during recovery from the moderate neuromuscular blockade. Korean J Anesthesiol. 2015 Dec — View Citation
Duvaldestin P, Kuizenga K, Saldien V, Claudius C, Servin F, Klein J, Debaene B, Heeringa M. A randomized, dose-response study of sugammadex given for the reversal of deep rocuronium- or vecuronium-induced neuromuscular blockade under sevoflurane anesthesia. Anesth Analg. 2010 Jan 1;110(1):74-82. doi: 10.1213/ANE.0b013e3181c3be3c. Epub 2009 Nov 21. — View Citation
Pühringer FK, Gordon M, Demeyer I, Sparr HJ, Ingimarsson J, Klarin B, van Duijnhoven W, Heeringa M. Sugammadex rapidly reverses moderate rocuronium- or vecuronium-induced neuromuscular block during sevoflurane anaesthesia: a dose-response relationship. Br — View Citation
Schaller SJ, Fink H, Ulm K, Blobner M. Sugammadex and neostigmine dose-finding study for reversal of shallow residual neuromuscular block. Anesthesiology. 2010 Nov;113(5):1054-60. doi: 10.1097/ALN.0b013e3181f4182a. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Noninvasive mean arterial pressure | Mean arterial blood pressure measurements during operation and after operation | During operation every 5 minutes and after operation in the recovery room every five minutes until discharge. | |
Other | Heart rate | Heart rate measurements during operation and after operation | During operation every 5 minutes and after operation in the recovery room every five minutes until discharge. | |
Other | Peripheral oxygen saturation | Peripheral oxygen saturation during operation and after operation | During operation every minute and after operation in the recovery room every minute until discharge. | |
Primary | Incidence of postoperative residual neuromuscular blockade (rNMB) | Incidence of postoperative residual neuromuscular blockade (rNMB) (defined as a train-of-four ratio, TOFR <0.9) measured 15 min after administration of the reversal agent. | After operation within 24 hours | |
Primary | Recovery time-1 | The comparison of the recovery periods between groups when the start of administering reversal agent to the recovery of TOF ratio < 0.9 to 0.7 | After operation within 120 minutes | |
Primary | Recovery time-2 | The comparison of the recovery periods between groups when the start of administering reversal agent to the recovery of TOF ratio < 0.7 | After operation within 120 minutes | |
Primary | Recovery time-3 | The comparison of the recovery periods between groups when the start of administering reversal agent to the recovery of TOF ratio= 0.9 | After operation within 24 hours | |
Primary | Muscle strength after extubation | The clinical assessment of muscle strength in the operating room are as follows; awake status, The investigated parameters were; arousable with minimal stimulation, cooperativeness, responsive only to tactile stimulation, cooperativeness, and able to perform five-second head lift. | After operation within 24 hours | |
Secondary | Adverse events-1 | Adverse events related to administration of reversal medications | After operation within 24 hours | |
Secondary | Adverse events-2 | Adverse events related to residual paralysis | After operation within 24 hours | |
Secondary | Rescue medication neostigmine | A rescue dose of intravenous neostigmine at a dose of 0.03 mg/kg in the operating room after 15 minutes before discharge to recovery room. | After operation within 120 minutes | |
Secondary | Rescue medication sugammadex | A rescue dose of intravenous sugammadex at a dose of 1 mg/kg in the recovery room after 15 minutes before discharge to the ward from recovery room | After operation within 120 minutes | |
Secondary | Time frame-1 | The time period between the last dose of intravenous rocuronium and administering a reversal agent | After operation within 30 minutes | |
Secondary | Time frame-2 | The time period between administering a reversal agent to extubation | After operation within 30 minutes | |
Secondary | Time frame-3 | The time period between administering a reversal agent to operating room discharge | After operation within 60 minutes | |
Secondary | Time frame-4 | The time period between discharge from the operating room amd discharge from recovery room | After operation within 120 minutes | |
Secondary | Aldrete Score greater than nine in the recovery room | The criteria for patient discharge from the recovery room | After operation within 120 minutes |
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