Status:
UNKNOWN
Reversal With Low Doses of Sugammadex in Patients Undergoing Non-cardiac Surgery
Lead Sponsor:
The Hospital of Vestfold
Conditions:
Postoperative Residual Curarization
Neuromuscular Block
Eligibility:
All Genders
18-100 years
Phase:
PHASE4
Brief Summary
Neuromuscular blocking agents (NMBA) are among the most commonly used drugs during general anesthesia and may induce complete muscle paralysis.They are used clinically to facilitate endotracheal intub...
Detailed Description
Doses of study drug will be 0 mg/kg Ideal Body Weight (IBW), 0.25 mg/kg IBW, 0.50 mg/kg IBW, 1.0 mg/kg IBW and 2.0 mg/kg IBW. TOF will be measured every 10th second until full reversal.
Eligibility Criteria
Inclusion
- Patient, both genders, undergoing any elective in-hospital surgical procedure under general anesthesia requiring rocuronium neuromuscular block.
- ASA I-IV
- Signed informed consent
Exclusion
- Patient less than 18 years of age
- Patient participating in another clinical study which could interfere with TOF trial.
- Patient with neuromuscular disease
- Patient from ICU
- BMI \> 30.0 kg/m2
- Patient scheduled for local or regional anesthesia only
- Patient undergoing general anesthesia without rocuronium
- Patient with hypersensitivity to NMBAs or sugammadex. Also hypersensitivity to any active substance or to any of the following excipient: Hydrochloric acid 3.7% (to adjust pH) and/or sodium hydroxide (to adjust pH) Water for injections .
- Renal dysfunction (GFR\<30 mL/min/1,73m2)
- Hepatic dysfunction
- Patient who have received sugammadex in the last 24 h.
- Pregnant or breastfeeding woman. Women in childbearing age must have a negative pregnant test before inclusion.
- Bradycardia (puls \<40)
- Hypotension (Systolic BP \<90 mmHg)
Key Trial Info
Start Date :
August 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2019
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT03460509
Start Date
August 1 2018
End Date
December 1 2019
Last Update
May 30 2018
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