post-operative alertness and recovery street fitness
Conditions
Interventions
Anesthesia will be standardized according to the usual protocol. At the end of
the surgery when TOF ratio is ~0,9, and approximately 70-80% of nicotine
receptors are still blocked by rocuronium, pat
Sponsors
Universitair Medisch Centrum Sint Radboud
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Males and females. - Age 18-65 years. - Able to perform the study assessments. - ASA classification 1 or 2 - Medical need for general anesthesia and neuromuscular blockade. - NMB with the standard dose of rocuronium. If the surgery lasts longer than 75 minutes the patient will be excluded. - Minor surgical and gynecological procedures that require tracheal intubation and mechanical ventilation. - Signed informed consent.
Exclusion criteria
Exclusion criteria: - Contra-indications for rocuronium, sugammadex, neostigmine and/or atropine. - Concomitant conditions or diseases that might interfere with the study assessments. - Concomitant treatment with any experimental drug within 4 weeks before surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| At baseline (1 day before surgery), and 30, 60, and 120 minutes after the TOF ratio of ~0,9 has been reached, the following commonly used, and non-invasive cognitive evaluations/scoring lists will be carried out in a subsequent order to assess recovery and psychomotor function: Modified Aldrete score The modified Aldrete score (see Appendix 2) assesses the degree of post-anesthesia recovery, based on ability to move extremities, respiration and circulation status, consciousness and oxygen saturation. Each item is scored from 0 (poor) to 2 (good). >=9 points are needed for recovery to be confirmed, i.e. the patient is ready for discharge from the PACU. Trail making test This test is used to measure visual conceptual and visual motor tracking 29. Normally, the entire test can be completed in 5 to 10 minutes. Only part A of this test will be performed. Since it is a test of speed, the examiner must stress the importance of time and efficiency. Part A consists of encircled numbers from 1 to 25 randomly spread across a sheet of paper. The object of the test is for the subject to connect the numbers in order, beginning with 1 and ending with 25, in as little time as possible. The number of failures to connect and the distance from the actual line to the number will be determined. Maddox wing test With the Maddox Wing instrument an imbalance in the extra-ocular muscles of the eyes (degree of strabismus) will be measured, where the field of vision is divided by oblique and vertical wings such that the arrow is seen by the right eye and a numbered scale in prism diopters by the left. Visual Analogue Scales for patient and observer to rate post-operative alertness and recovery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Additional relevant data to be collected include gender, age, relevant medical history, type of surgery, anticipated duration of surgery, total dose of propofol and remifentanil, total dose of rocuronium, time of rocuronium administration(s) relative to start of anesthesia (T=0), other drugs administered for medical reasons that could influence the outcome of the study evaluations, end of surgery relative to T=0, time TOF~ 0,9 has been reached relative to T=0, time start and end of evaluations relative to T=0, any perioperative complication, and adverse events. | — |
Countries
Netherlands
Outcome results
None listed