Effect of Deep BLock on Intraoperative Surgical Conditions
Ključne riječi
Sažetak
Opis
Surgical conditions in laparoscopic surgery are largely determined by the degree of neuromuscular relaxation during surgery. Especially in procedures which are confined to a narrow working field such as renal and prostatic laparoscopic surgery, deep neuromuscular relaxation may be beneficial. Until recently however, deep neuromuscular block (1-2 twitches post tetanic count) came at the expense of a variety of items that conflicted with its use. Occurrence of postoperative residual neuromuscular blockade after deep neuromuscular block was a common adverse event. Residual neuromuscular block is a risk factor for developing airway obstruction and pulmonary complications such pneumonia and atelectasis. The use of acetylcholinesterase inhibitors, like neostigmine, as a traditional neuromuscular blocking reversal agent, have a slow onset of action. Side effects due to muscarine receptor stimulation are bradycardia, hypersalivation, nausea and vomiting. Coadministration of a muscarine agonist like atropine is often necessary to address the heart rate-related side effects of neostigmine. Atropine, however, in itself may induce other side effects.
Rapid, safe and complete reversal of neuromuscular blockade was not possible until the discovery of Sugammadex. Sugammadex is a modified y-cyclodextrin. It was developed to selectively bind free plasma rocuronium, a non-depolarizing steroidal neuromuscular blocking agent. By binding free rocuronium, less rocuronium becomes available at the neuromuscular junction to bind to the muscarine receptor. Non-depolarizing neuromuscular blocking agents (NMBA's) block the muscarine receptor at the neuromuscular junction, making them unavailable to acetylcholine based signal transmission. Sugammadex has proven to rapidly and safely reverse rocuronium and vecuronium. Even high dose rocuronium (1.2 mg/kg and continuous rocuronium infusion used to achieve deep neuromuscular blockade can safely be reversed by Sugammadex.
Theoretically, the availability of Sugammadex makes it possible to use deep neuromuscular block (DNB) during surgery to improve surgical conditions without the occurrence of the above-mentioned adverse events. The use of DNB to improve surgical conditions, however, has not yet been evaluated. The investigators therefore aim to investigate the use of rocuronium induced-DNB in renal and prostatic laparoscopic surgery. Current anesthesiologic practice during these procedures in the LUMC consists of an intravenous (propofol) or volatile (sevoflurane) anesthetic combined with mivacurium and atracurium to achieve a moderately deep neuromuscular block (0-2 twitches TOF). Reversal of NMB is by the neostigmine atropine combination. In the current study the investigators will assess the effect of a DNB (1-2 twitches post tetanic count) using a continuous rocuronium infusion on surgical conditions. After surgery Sugammadex 4 mg/kg will be used to safely and rapidly reverse the neuromuscular blockade within 5-min.
The main end-point of the study is the effect of the deep block on the surgical conditions. The investigators will study these conditions using two methods. (1) Assessment of the surgical condition by the operating surgeon (all surgeries will be performed by one surgeon), using a 5-point rating surgical rating scale from 1 (= extremely poor surgical condition) to 5 = optimal surgical condition. (2) Video images, used by the surgeon to perform the surgery, will be rated by a team of surgical and non-surgical experts. Apart from the additional scoring data, this approach allows for the validation of the surgical rating scale.
Minor end-points of the study are (1) measurement of hemodynamics during surgery using a non-invasive cardiac output and blood pressure device. Assuming that intra-abdominal pressure will affect the venous return and hence cardiac output during surgery, a deep neuromuscular block might affect the hemodynamic parameters positively; (2) measurement of respiration, pain, and alertness in the recovery room to assess whether reversal with Sugammadex influences these parameters positively compared to neostigmine/atropine reversal.
Datumi
Posljednja provjera: | 07/31/2016 |
Prvo podneseno: | 06/18/2012 |
Predviđena prijava poslana: | 06/26/2012 |
Prvo objavljeno: | 06/27/2012 |
Posljednje ažuriranje poslano: | 08/22/2016 |
Posljednje ažuriranje objavljeno: | 10/16/2016 |
Datum prvog podnošenja rezultata: | 04/11/2013 |
Datum prvog podnošenja rezultata QC: | 08/22/2016 |
Datum prvog objavljivanja rezultata: | 10/16/2016 |
Stvarni datum početka studija: | 05/31/2012 |
Procijenjeni datum primarnog završetka: | 02/28/2013 |
Procijenjeni datum završetka studije: | 02/28/2013 |
Stanje ili bolest
Intervencija / liječenje
Drug: Deep surgical block
Drug: Moderate/normal surgical block
Faza
Grupe ruku
Ruka | Intervencija / liječenje |
---|---|
Experimental: Deep surgical block Continuous rocuronium infusion will be used to induce a deep surgical block with post tetanic twitch count of max 2. Rocuronium loading dose = 1.0 mg/kg, followed by 0.6-1.0 mg/kg per hour. | Drug: Deep surgical block The surgical block will be varied by either induction of a deep block (via rocuronium infusion) or a moderate/normal block (using atracurium/mivacurium infusion) |
Active Comparator: Moderate/normal surgical block A normal block will be induced by an atracurium bolus dose followed by a mivacurium infusion to induce a train of four count of 1-2. | Drug: Moderate/normal surgical block A surgical block will be induced by infusion of either rocuronium (deep block) or atracurium/mivacurium (normal/moderate block) |
Kriterij prihvatljivosti
Dobni uvjeti za studiranje | 18 Years Do 18 Years |
Spolovi koji ispunjavaju uvjete za studij | All |
Prihvaća zdrave volontere | Da |
Kriteriji | Inclusion Criteria: - Patients diagnosed with renal or prostatic disease who are will undergo an elective laparoscopic renal surgical procedure or laparoscopic prostatectomy; - ASA class I-III - > 18 years of age; - Ability to give oral and written informed consent Exclusion Criteria: - Known or suspected neuromuscular disorders impairing neuromuscular function; - Allergies to muscle relaxants, anesthetics or narcotics; - A (family) history of malignant hyperthermia; - Patients who have a contraindication for neostigmine administration; - 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. When available, other indices will be taken into account as well such as glomerular filtration rate < 60 ml/h and proteinuria (a ratio of 30 mg albumin to 1 g of creatinine). - Previous retroperitoneal surgery at the site of the current surgery. - Body mass index > 35 kg/m2 |
Ishod
Primarne mjere ishoda
1. Surgical Rating Scale [Measurements will be made during the stay in the operating room for an average period of 3 hours]
Sekundarne mjere ishoda
1. Breathing [Measurements will be made during the stay in the recovery room for an average period of 3 hours]
2. Post-operative Pain [measurements are made in the recovery room following surgery for an average prior of 1 hour]
3. Postoperative Sedation Score [Measurements will be made during the stay in the operating room for an average period of 3 hours]
4. Nausea and Vomiting [Measurements will be made during the stay in the operating room for an average period of 3 hours]