Laparoscopy Clinical Trial
— DEEPBLOCKOfficial title:
A Randomized Trial of Deep Neuromuscular Blockade Reversed With Sugammadex Versus Moderate Neuromuscular Block Reversed With Neostigmine, on Postoperative Quality of Recovery
Verified date | April 2020 |
Source | University of Melbourne |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Trial summary: deep neuromuscular block is proposed as a technique to improve operative conditions for laparoscopy. Early clinical data would suggest that there may also be patient benefits beyond the operative period related to lower intra-abdominal pressure, and improved surgical exposure. In order to safely conduct deep neuromuscular blockade, it is essential to use Sugammadex to reverse the neuromuscular block. Conventional practice is to provide moderate neuromuscular block and reverse with neostigmine. It is not possible to safely reverse deep neuromuscular block using neostogmine, as the majority of block must have worn off for neostigmine to be effective. in order to identify whether deep neuromuscular block improves quality of recovery after surgery, the investigators will conduct a randomised trial of deep versus moderate neuromuscular block, whilst minimising variance in other anaesthetic techniques and drugs used. the outcome measured will be the post-operative quality of recovery over multiple time periods using the Postoperative Quality of Recovery Scale (PostopQRS). 350 patients will be enrolled over 4 centres.
Status | Completed |
Enrollment | 350 |
Est. completion date | April 1, 2019 |
Est. primary completion date | February 15, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Adult participants 2. operative gynecological or abdominal surgery 3. receiving general anesthesia 4. Operation expected to exceed1 hour duration 5. Participants must speak sufficient English to answer the survey questions Exclusion Criteria: 1. Participants undergoing diagnostic laparoscopy only 2. Participants <18 years of age 3. Current pregnancy 4. Known allergy to rocuronium, neostigmine or sugammadex, or desflurane |
Country | Name | City | State |
---|---|---|---|
Australia | Northpark Private Hospital | Bundoora | Victoria |
Australia | Melbourne Health | Parkville | Victoria |
Australia | The Royal Womens Hospital | Parkville | Victoria |
Australia | Victorian Comprehensive Cancer Centre | Parkville | Victoria |
Lead Sponsor | Collaborator |
---|---|
University of Melbourne | Melbourne Health, Northpark Private Hospital, Peter MacCallum Cancer Centre, Australia, Royal Hospital For Women |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Patients Recovered Cognitively at 1 Week | The primary outcome will be the cognitive domain at 1 week after surgery, when it is expected that most of the acute inflammation will have resolved, and analgesia requirements minimal. | 1 week | |
Secondary | Percentage of Patients Recovered in All Domains of the Postoperative Quality of Recovery Scale at 3 Months After the Operation | Recovery for all domains and within domains of the PostopQRS scale at the other time points of measurement (15 minutes, 40 minutes 1 day, 3 days, 1 and 2 weeks, and 3 months following cessation of anesthesia). The domains of recovery are physiological, nociceptive, emotive activities of daily living, cognitive and overall patient perspective. | 3 months | |
Secondary | Number of Participants With Full Reversal of Neuromuscular Blockade Prior to Extubation | Compliance with protocol to ensure deep block or light/moderate block, using the train of four ratio and post tetanic count | 6 hours | |
Secondary | Duration of Anesthesia From Induction to Cessation of the Anesthetic | Duration of Anesthesia from induction to cessation of the anesthetic up to 6 hours | Up to 6 hours | |
Secondary | Number of Participants Categorized by Level of Surgical Satisfaction | Overall surgical satisfaction using a 1-5 Likert scale (1 = very unacceptable, 2 = unacceptable, 3 = acceptable, 4 = good, 5 = excellent). | 2 hours | |
Secondary | Duration of Hospital Length of Stay | Duration of hospital length of stay following their procedure until hospital discharge | 3 days |
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