Cholecystectomy, Laparoscopic
Conditions
Brief summary
The purpose of this investigation is to compare the surgical conditions during laparoscopic cholecystectomy at a low intra-abdominal pressure with deep or moderate muscle relaxation. The primary hypothesis is that surgical conditions during laparoscopic cholecystectomy are better with deep muscle relaxation than moderate muscle relaxation.
Detailed description
The purpose of this investigation is to compare the surgical conditions with two degrees of neuromuscular blockade in patients who have laparoscopic cholecystectomy done with pneumoperitoneum 8 mmHg.
Interventions
DRUGRocuronium
Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h
Sponsors
Herlev Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients older than 18 years * Scheduled for elective laparoscopic cholecystectomy * Can read and understand danish * Women must be post-menopausal, sterilized or use safe contraception in the form of a coil or oral anti-contraceptives
Exclusion criteria
* Known allergy to medications that are included in the project * Presence of severe renal disease, neuromuscular disease, reduced liver function * Nursing or pregnant * Indication for crash induction * For fertile women: Missing negative pregnancy-test
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Patients With Optimal Surgical Space Conditions ( 1 at a 4-step Scale) Assessed at the Time During Surgery, When View Was Less | From surgical incision to last suture has been placed, an expected average of 30 minutes | The surgical space conditions (4-stage scale) assessed at the time during surgery, when view was less. The laparoscopies were performed by experienced surgeons, whom were asked to evaluate surgical space conditions with a 4-point scale : Grade 1 (optimal) = optimal surgical space conditions; Grade 2 (good) = non-optimal conditions, but an intervention was not considered; Grade 3 (acceptable) = an intervention was considered in order to improve surgical space; Grade 4 (poor) = inadequate conditions and an intervention was necessary in order to ensure acceptable surgical space. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgical Space Conditions | From surgical incision to last suture has been placed, an expected average of 30 minutes. | The surgical space conditions (VAS 0-100) assessed at the time during surgery, when they were poorest |
| Normal Functional Level | from the day of surgery to re-establishing normal functional level - an expected average of 7 days. | Numer of days before re-establing normal functional level |
| Surgical Procedures at Low Pneumoperitoneum | From surgical incision to last suture has been placed, an expected average of 30 minutes. | Number of procedures which can be done with pneumoperitoneum 8 mmHg |
| Duration of Surgery | From surgical incision to last suture has been placed. | Duration of surgery |
| Pain | Preoperatively to 7 days after surgery | Pain (shoulder, incision, deep abdominal and general) as the area under the curve from preoperatively to 7 days after surgery. |
| Consumption of Analgesics | The first 24 hours after surgery | Consumption of analgesics during the first 24 hours after surgery |
| Nausea and Vomiting | The first 24 hours after surgery | The incidence of nausea and vomiting during the first 24 hours after surgery |
| Anti-emetics | During the first 24 hours after surgery | Use of anti-emetics during the first 24 hours after surgery |
| Duration of Anesthesia | From induction of anesthesia to patient ready to leave the operating theatre | Duration of anesthesia |
Countries
Denmark
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Deep Neuromuscular Blockade Rocuronium: Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h | 25 |
| Moderate Neuromuscular Blockade Rocuronium: Intravenous use: 0,3 mg/kg followed by NaCl-infusion | 23 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | surgery cancelled | 0 | 1 |
Baseline characteristics
| Characteristic | Deep Neuromuscular Blockade | Moderate Neuromuscular Blockade | Total |
|---|---|---|---|
| Age, Continuous | 45 years | 48 years | 45 years |
| Region of Enrollment Denmark | 25 participants | 23 participants | 48 participants |
| Sex: Female, Male Female | 15 Participants | 17 Participants | 32 Participants |
| Sex: Female, Male Male | 10 Participants | 6 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 12 / 25 | 11 / 23 |
| serious Total, serious adverse events | 3 / 25 | 1 / 23 |
Outcome results
Primary
The Percentage of Patients With Optimal Surgical Space Conditions ( 1 at a 4-step Scale) Assessed at the Time During Surgery, When View Was Less
The surgical space conditions (4-stage scale) assessed at the time during surgery, when view was less. The laparoscopies were performed by experienced surgeons, whom were asked to evaluate surgical space conditions with a 4-point scale : Grade 1 (optimal) = optimal surgical space conditions; Grade 2 (good) = non-optimal conditions, but an intervention was not considered; Grade 3 (acceptable) = an intervention was considered in order to improve surgical space; Grade 4 (poor) = inadequate conditions and an intervention was necessary in order to ensure acceptable surgical space.
Time frame: From surgical incision to last suture has been placed, an expected average of 30 minutes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Deep Neuromuscular Blockade | The Percentage of Patients With Optimal Surgical Space Conditions ( 1 at a 4-step Scale) Assessed at the Time During Surgery, When View Was Less | 28 percentage of patients |
| Moderate Neuromuscular Blockade | The Percentage of Patients With Optimal Surgical Space Conditions ( 1 at a 4-step Scale) Assessed at the Time During Surgery, When View Was Less | 4 percentage of patients |
Secondary
Anti-emetics
Use of anti-emetics during the first 24 hours after surgery
Time frame: During the first 24 hours after surgery
Secondary
Consumption of Analgesics
Consumption of analgesics during the first 24 hours after surgery
Time frame: The first 24 hours after surgery
Secondary
Duration of Anesthesia
Duration of anesthesia
Time frame: From induction of anesthesia to patient ready to leave the operating theatre
Secondary
Duration of Surgery
Duration of surgery
Time frame: From surgical incision to last suture has been placed.
Secondary
Nausea and Vomiting
The incidence of nausea and vomiting during the first 24 hours after surgery
Time frame: The first 24 hours after surgery
Secondary
Normal Functional Level
Numer of days before re-establing normal functional level
Time frame: from the day of surgery to re-establishing normal functional level - an expected average of 7 days.
Secondary
Pain
Pain (shoulder, incision, deep abdominal and general) as the area under the curve from preoperatively to 7 days after surgery.
Time frame: Preoperatively to 7 days after surgery
Secondary
Pain
Pain (shoulder, incision, deeop abdominal and general) at arrival to the postanesthesia care department, 2 hours and 1 day after surgery.
Time frame: At arrival to the postanesthesia care department, 2 hours and 1 day after surgery
Secondary
Surgical Procedures at Low Pneumoperitoneum
Number of procedures which can be done with pneumoperitoneum 8 mmHg
Time frame: From surgical incision to last suture has been placed, an expected average of 30 minutes.
Secondary
Surgical Space Conditions
The surgical space conditions (VAS 0-100) assessed at the time during surgery, when they were poorest
Time frame: From surgical incision to last suture has been placed, an expected average of 30 minutes.
Secondary
Surgical Space Conditions
The surgical space conditions during dissection of the gallbladder (4-stage scale and VAS 0-100).
Time frame: During dissection of the gallbladder
Secondary
Surgical Space Conditions
The average surgical space conditions (VAS 0-100 and 4-stage scale) during the procedure.
Time frame: From surgical incision to last suture has been placed, an expected average of 30 minutes.