Phase 4
Completed N=127
A Study Comparing the Use of Deep or Standard Neuromuscular Blockade in Combination With Low or Standard Insufflation Pressures in Participants Undergoing Laparoscopic Cholecystectomy (P07982)
Gallbladder Disease
Source: ClinicalTrials.gov NCT01728584 ↗
Enrolled (actual)
127
Serious AEs
3.3%
Results posted
Mar 2015
Primary outcomePrimary: Score on Surgeon's Assessment of Overall Satisfaction With the Surgical Conditions: By Depth of NMB (Standard, Deep) and Insufflation Pressure (Standard, Low) — 6.83; 7.92; 8.89; 5.87 score on a scale — p=0.026
Summary
The purpose of this pilot study is to compare the use of deep or standard neuromuscular blockade (NMB) in combination with low or standard insufflation pressure in participants undergoing a surgical procedure, laparoscopic cholecystectomy. Insufflation refers to the injection of carbon dioxide into the abdomen during the laparoscopic surgery, to allow visualization of and access to the surgical field. The primary hypothesis of the study is that the use of sustained deep NMB improves the surgeon's overall satisfaction with surgical conditions as compared to standard NMB. The in-patient surgery is performed on Day 1 and the participant remains hospitalized for at least 48 hours following the surgery (or at least 24 hours following the surgery, if local practice does not allow 48 hours of hospitalization post surgery). On Day 8, a follow-up visit/contact including all participants occurs.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Score on Surgeon's Assessment of Overall Satisfaction With the Surgical Conditions: By Depth of NMB (Standard, Deep) and Insufflation Pressure (Standard, Low) |
6.83; 7.92; 8.89; 5.87 | 0.026 sig |
| PRIMARY Score on Surgeon's Assessment of Overall Satisfaction With the Surgical Conditions: By Treatment Arm |
8.65; 4.99; 9.09; 6.69 | — |
| SECONDARY Participant's Overall Average Pain Score in the First 24 Hours After Administration of Sugammadex: By Depth of NMB (Standard, Deep) and Insufflation Pressure (Standard, Low) |
2.48; 2.83; 2.74; 2.57 | 0.148 |
| SECONDARY Participant's Overall Average Pain Score in the First 24 Hours After Administration of Sugammadex: By Treatment Arm |
2.42; 2.62; 3.06; 2.57 | — |
| SECONDARY Score on Surgeon's Assessment of Overall Satisfaction With the Visibility of the Surgical Field: By Depth of NMB (Standard, Deep) |
6.88; 7.80 | 0.063 |
| SECONDARY Score on Surgeon's Assessment of the Overall Adequacy of Muscle Relaxation During Surgery: By Depth of NMB (Standard, Deep) |
8.05; 8.87 | 0.004 sig |
| SECONDARY Score on Surgeon's Assessment of the Overall Adequacy of Insufflation Pressure During Surgery: By Depth of NMB (Standard, Deep) |
6.73; 7.86 | 0.006 sig |
| SECONDARY Number of Times Participant's Movements or Increased Muscle Tone Interfered With the Surgical Conditions During Laparoscopy: By Depth of NMB (Standard, Deep) |
0.92; 0.32 | 0.073 |
| SECONDARY Score on Surgeon's Assessment of the Effect Participant's Movements During Surgery Had on the Overall Surgical Procedure: By Depth of NMB (Standard, Deep) |
9.21; 9.94 | 0.009 sig |
| SECONDARY Number of Participants With Rescue Actions Performed During Surgery in Order to Improve Insufficient Surgical Conditions: By Treatment Arm |
0; 7; 0; 5; 0; 5 | — |
| SECONDARY Participant's Daily Assessment of Overall Pain at Rest During Post Operative Period: By Treatment Arm |
1.66; 2.23; 2.24; 2.48; 1.22; 1.41 | — |
| SECONDARY Participant's Daily Assessment of Provoked Pain During Post Operative Period: By Treatment Arm |
3.38; 3.27; 3.68; 3.76; 2.67; 2.14 | — |
| SECONDARY Participant's Daily Assessment of Shoulder Pain During Post Operative Period: By Treatment Arm |
1.00; 1.18; 1.05; 1.40; 0.41; 0.64 | — |
| SECONDARY Number of Participants Using Pain/Analgesic Medication During Post Operative Period: By Treatment Arm |
31; 21; 37; 24; 26; 21 | — |
Eligibility Criteria
Inclusion Criteria
- American Society of Anesthesiologists (ASA) Class 1 or 2 or 3
- Scheduled to undergo an elective in-patient laparoscopic cholecystectomy procedure under general anesthesia with total intravenous anesthesia (TIVA) using propofol and remifentanil
- Eligible to undergo rocuronium-induced NMB for endotracheal intubation and maintenance of NMB
- Will recover in the post-anesthesia care unit (PACU) and remain in the hospital for at least 48 hours following the surgical procedure (or at least 24 hours following the surgical procedure, if local practice does not allow 48 hours of hospitalization post surgery)
- Body mass index (BMI) ≤35
- Willing and able to adhere to visit schedules including all required study assessments on Day 3 through 8 (daily pain and medication diary entry)
- For sexually active female participants of child-bearing potential - able to use a medically accepted method of contraception through 7 days after receiving protocol-specified medication
Exclusion criteria
- Neuromuscular disorders that may affect NMB and/or trial assessments
- Lifetime history of previous abdominal surgery, including laparotomies, Cesarean section, laparoscopic procedures or diagnostic laparoscopies
- Substance abuse or dependence (excluding nicotine) within the past 6 months
- History of a chronic pain condition (requiring continuous/daily pain medication prior to surgery)
- For female participants - lifetime history of a Cesarean section, or has given birth to one or more children within the last year, or is currently pregnant or has the intention to become pregnant between randomization and pregnancy follow-up contact ≥30 days after administration of trial treatments (rocuronium, sugammadex)
- Evidence of acute cholecystitis
- Dialysis-dependency or suspected of having severe renal insufficiency
- Significant hepatic dysfunction that would prevent participation in the trial
- History of or family history of malignant hyperthermia
- Allergy to trial treatments (rocuronium or sugammadex) or their excipients, to opioids/opiates, or other medication used during general anesthesia
- Received or is planned to receive toremifene or fusidic acid within 24 hours before or after receiving rocuronium or sugammadex
- Expected transfer to an Intensive Care Unit after surgery
- Any clinically significant condition or situation, other than the reason for the cholecystectomy that would interfere with the trial evaluations or optimal participation in the trial
- Used any investigational drugs within 30 days of randomization
- Participated in any other clinical trial within 30 days of signing the informed consent form of the current trial
- Participated in any other clinical trial involving any personnel of the investigational or Sponsor staff directly involved with this trial
- Is a family member of any personnel of the investigational or Sponsor staff directly involved with this trial
Data sourced from ClinicalTrials.gov (NCT01728584). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.