Clinical trial NCT02794714: Deep vs Moderate Block: Impact on Operating Conditions & Patient Satisfaction
Official title: Comparing Deep Neuromuscular Block and Moderate Neuromuscular Block in Patients Undergoing Laparoscopic Gynaecological Surgeries: Impact on Surgical Satisfaction of Operating Conditions and Patient Satisfaction
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Neuromuscular Blockade
Keywords: Laparoscopic Gynecologic Surgeries
Lead sponsor: Kuala Lumpur General Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2016-06-09
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compares surgeon's satisfaction of operating conditions and patient's satisfaction following laparoscopic gynecological surgeries in two groups of patients, half of whom will receive deep neuromuscular blockade and the other half, moderate neuromuscular blockade.

Detailed description: Deep neuromuscular blockade in anesthesia has been shown to improve operating conditions in retroperitoneal surgeries, while there is minimal evidence regarding this method in laparoscopic gynecological procedures.The advantage of improving surgical conditions with a deep neuromuscular blockade in laparoscopic surgery may however lead to a delayed neuromuscular recovery and hence a delay in turnover of patients.

Rocuronium will be used for muscle relaxation in order to achieve the necessary depth of neuromuscular blockade. Sugammadex is a modified cyclodextrin that forms complexes with rocuronium, reducing free plasma concentrations of rocuronium and reversing its neuromuscular blocking action from any depth.

The use of rocuronium will therefore aid in achieving a deep neuromuscular blockade which the investigators postulate will improve surgical conditions and the reversal with sugammadex will ensure a rapid recovery thereafter.

Eligibility criteria: Inclusion Criteria:

1. Patients identified from the anaesthetic clinic scheduled to undergo a laparoscopic gynaecological procedure under general anaesthesia

   * requiring tracheal intubation
   * elective surgeries (eg. laparoscopy \& dye insufflation, bilateral tubal ligation, cystectomy, myomectomy, hysterectomy, salpingo-oophorectomy)
2. American Society of Anaesthesiology (ASA) I-II

Exclusion Criteria:

1. Anticipated difficult airway
2. Patients requiring rapid sequence induction
3. Patient anticipated to require admission to the intensive care unit (ICU) or not planned for extubation
4. Patient with liver or renal failure (creatinine clearance \<50mls/min)
5. Patients with a baseline heart rate \<50/min
6. Patients with documented or suspected neuromuscular disorder

   * Guillain - Barre syndrome
   * Cerebrovascular accidents with residual neurology
   * Parkinson's Disease
   * Myasthenia Gravis
7. Any condition making the administration of patient satisfaction questionnaire difficult/impossible

   • speech or hearing impairment and language barriers
8. Patients on fusidic acid or toremifene 24 hours before surgery
9. Patients on hormonal contraceptives; oral or otherwise
10. Patients on drugs, medical problems that may prolong or shorten the duration of rocuronium- (eg.. aminoglycosides, magnesium)
11. Patients with a history of allergy to rocuronium or sugammadex

Primary outcomes:
measure: Deep block versus Moderate block: Impact on surgical satisfaction
timeFrame: Every 15 minutes from first laparoscopic view till the removal of laparoscopes at the end of surgery or up to 8 hours from 1st score.
Secondary outcomes:
measure: Deep block versus Moderate block: Patient satisfaction score
timeFrame: Post Anesthetic Recovery Score done at half hour from time of arrival at PACU and patient deemed fit for discharge up to 2 hours from time of arrival at PACU
measure: Deep block versus Moderate block: Pain score
timeFrame: Post Anesthetic Recovery Score done at half hour from time of arrival at PACU and patient deemed fit for discharge up to 2 hours from time of arrival at PACU
measure: Deep block versus Moderate block: PONV Score
timeFrame: Post Anesthetic Recovery Score done at half hour from time of arrival at PACU and patient deemed fit for discharge up to 2 hours from time of arrival at PACU
Other outcomes:
Locations:
Study officials:
affiliation: Kuala Lumpur General Hospital
name: Vanitha Sivanaser, M.Med Anaes (UM)
role: PRINCIPAL_INVESTIGATOR
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