Surgical Conditions Clinical Trial
— BLISS3Official title:
Effect of Depth of Neuromuscular Block on Intraoperative Surgical Conditions as Determined by the Leiden Surgical Rating Scale in Morbidly Obese Patients Undergoing Laparoscopic Bariatric Surgery
This is a randomized control trial (RCT) that studies the surgical conditions during moderate and deep neuromuscular blockade in 100 morbidly obese patients receiving elective laparoscopic surgery for bariatric surgery.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | |
Est. primary completion date | February 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - ASA I-III - BMI > 34 kg/m2 - Elective bariatric surgery. Exclusion Criteria: - Known or suspected neuromuscular disorders impairing neuromuscular function - Allergies to muscle relaxants, anesthetics or narcotics - A(family) history of malignant hyperthermia - Women who are or may be pregnant or are currently breast feeding - Renal insufficiency, as defined by serum creatinine x 2 of normal, or urine output < 0.5 ml/kg/h for at least 6 h. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Netherlands | Leiden University Medical Center | Leiden | Zuid-Holland |
Netherlands | Medisch Centrum Haaglanden / Nederlandse Obesitas Kliniek | The Hague | Zuid Holland |
Lead Sponsor | Collaborator |
---|---|
Leiden University Medical Center | Medical Center Haaglanden, Merck Sharp & Dohme Corp. |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | surgical rating | During a procedure, the surgical condition will be scored by one surgeon using a 5-point surgical rating. This will be done at 10 min intervals from the start of surgery until the end of surgery scale. The rating scale is a 5-point ordinal scale ranging from 1 = poor condition to 5 = optimal surgical conditions. The mean difference in ratings between procedures under deep neuromuscular block and those during moderate neuromuscular block will be evaluated. | intraoperative | No |
Secondary | Extubation | The investigators will assess the time from the injection of the reversal agent until the time to removal of the endotracheal tune (extubation). | intraoperative | No |
Secondary | Pain | pain will be scored using numeric rating scale (0-10) at 10 minute intervals at the post anesthesia care unit | up to 2 hours postoperative | No |
Secondary | Respiration | Respiration will be measured by counting the respiratory rate at 10 min interval for 2 hours in the post anesthesia care unit. The breaths per min (unit 1/min) will be logged. | 2 hours postoperative | No |
Secondary | Hemodynamics | Hemodynamics will be monitored at 10 minute intervals for 2 hours in the post anesthesia care unit by measurement of heart rate (unit 1/min) and diastolic and systolic blood pressure (unit mm Hg). | 2 hours postoperative | No |
Secondary | Quality of Recovery Score | Postoperative Quality of Recovery Score at 10 min and at 40 min in the recovery room (one additional measurement will be obtained at day 1 after surgery); one additional measurement will be at 18-24 h post operative. | At 10 and 40 minutes after arrival on PACU, and 18-24 hr postoperatively on ward | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02079337 -
Validation of Subjective Rating Scales Used to Assess Surgical Conditions in Abdominal Surgery
|
Phase 4 | |
Completed |
NCT03170661 -
Effect of Deep Versus Moderate Neuromuscular Block During Sevoflurane Anesthesia on Intraoperative Surgical Conditions.
|
Phase 4 | |
Not yet recruiting |
NCT04850404 -
Effect of the Sheath of Rectus Abdominis Block Combined With the Transverse Plane
|
N/A | |
Completed |
NCT01748643 -
CURES: The Effect of Deep Curarisation and Reversal With Sugammadex on Surgical Conditions and Perioperative Morbidity
|
Phase 4 |