Muscle Weakness Clinical Trial
Official title:
Deep Versus Moderate Neuromuscular Blockade for Optimising Surgical Conditions Include Patient Benefits During Spinal Surgery: A Randomized Controlled Double Blinded Clinical Study
In the present study, the investigators compare intermediate and deep NMB i.e. the two
extreme regimes of muscle paralysis (neuromuscular block; NMB), (I) patients receiving
intermediate muscle paralysis (''control, conventional NMB'') versus (II) patients with a
deep neuromuscular blockade with rocuronium (''Deep NMB''), will be compared during a
surgical procedure which is considered to be very sensitive for inadequate muscle relaxation,
elective minimally invasive spinal surgery.
The primary objective of this trial is to compare the operation time reduction with the help
of the decreased stiffness of targeted back muscle surrounding the surgical field.
The changed back muscle stiffness also measured as secondary objective goal by a mechanical
tension weighing scale and also taking ultrasonography using shear wave elastography (SWE).
Other observational objectives are divided into the following categories of stakeholders:
patients, surgeons and anesthesiologists', done by collecting the variety of clinical
parameters. The following will be collected and compared.
1. For patients Intraoperative radiation amount, post-anesthetic care unit(PACU) stay,
transfer rate to SICU for post-op. care, post-operative respiratory complication rate,
and total hospital costs.
2. For surgeons Post-operative complications in regard to operation field, and evaluate
surgical conditions using a Visual Analogue Scale(VAS score) in surgeon's side.
3. For anesthesiologists Intraoperative ventilation parameters of patients, and evaluate
surgical conditions using a Visual Analogue Scale(VAS score) in anesthesiologist's side.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | May 1, 2019 |
Est. primary completion date | March 28, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility |
Inclusion Criteria: - All patients had to be scheduled by the surgeons for an elective spinal surgery required correction of 1 to 3 segment level of spine under general anesthesia. - Patients with ASA-classification (the American Society of Anesthesiologists) physical status classed as I to II aged 19 years old and over will be enrolled. Exclusion Criteria: - expected a difficult airway - known neuromuscular disease - known allergy or hypersensitivity to one of the drugs used in this study - intake of any medication that might interact with muscle relaxants. - Female subjects will be excluded if they were either pregnant, of childbearing potential, not using a mechanical method of birth control, or if they were breast-feeding. - subjects who are unable to understand or successfully administer a patient controlled analgesia (PCA) device, - subjects who are declined to participate during the protocol |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Yeouido St. Mary's Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
The Catholic University of Korea |
Korea, Republic of,
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* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | post-anesthetic care unit stay | time duration during post-anesthetic care unit stay | 1 hour after operation | |
Other | transfer rate to intensive care unit | 1 hour after operation | ||
Other | post-op pain score | post operative pain is measured when 30 minutes, 6 hours, 12 hours, 24 hours, 48 hours postoperatively using visual analogue scale. | 30minutes, 6hours, 12hours, 48hours after operation | |
Other | post-op nausea and vomiting(PONV) | post operative nausea and vomiting is measured when 30 minutes, 6 hours, 12 hours, 24 hours, 48 hours postoperatively using visual analogue scale. | 30minutes, 6hours, 12hours, 48hours after operation | |
Other | total hospital cost | calculated in KRW | 4 weeks after operation | |
Other | surgical condition | evaluate surgical conditions using a Visual Analogue Scale(VAS score) asked to surgeon and anesthesiologist, respectively. | Intraoperative | |
Other | intraoperative ventilation parameters (1. lung compliance) | lung compliance is measured by anesthetic machine ( GE Avance) | Intraoperative | |
Other | intraoperative ventilation parameters (2. peak airway pressure) | peak pressure is measured by anesthetic machine ( GE Avance) | Intraoperative | |
Primary | the operation time | Primary endpoint: To compare the measurements of the operation time reduction, the operation time should be recorded by institutional electronic medical chart from the incision to the final suture closure of surgical wound. A difference of 10% change of operation time between two groups is considered of clinically meaningful difference. |
Intraoperative | |
Secondary | back muscle stiffness ( 1. Shear Wave Ultrasound Elastography(SWE) ) | 1. Shear Wave Ultrasound Elastography(SWE): SWE score value will be collected 3 times as followings. First, After enrolled, the obtained informed consent for this clinical study and screening, SWE score measure will be taken prior to surgery as a basal value from the patient. Second, After Induction and patient positioning, measure the targeted back muscle stiffness by using ultrasonography of SWE. Third, SWE score measure finally after the stich out before the discharge. |
Intraoperative | |
Secondary | back muscle stiffness (2.Mechanical Tension Weighing Scale (MTWS) of mechanical dynamometer) | 2. Mechanical Tension Weighing Scale(MTWS) of mechanical dynamometer: After surgical incision, measure the targeted back muscle stiffness by using MTWS. It will be compared between the study groups. | Intraoperative |
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