Deep vs Moderate Block: Impact on Operating Conditions & Patient Satisfaction

Kuala Lumpur General Hospital

Status and phase: Withdrawn; Phase 4

Conditions: Neuromuscular Blockade

Treatments: Drug: Deep neuromuscular blockade; Drug: Moderate neuromuscular blockade

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02794714

CVL#123

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

deep neuromuscular blockade

Experimental group

Description:

Rocuronium will be administered to achieve PTC 1-2 throughout surgery.

Treatment:

Drug: Moderate neuromuscular blockade

moderate neuromuscular blockade

Active Comparator group

Description:

Rocuronium will be administered to achieve TOFC 2 throughout surgery

Treatment:

Drug: Deep neuromuscular blockade