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Introduction- During laparoscopic procedures surgical field exposure is one of the crucial aspects for a successful surgery. Exposure can be optimized by pneumoperitoneum, positioning of the patient and muscle relaxation.
The European Association for Endoscopic Surgery has recommended using the lowest intraperitoneal pressure allowing adequate exposure of the operative field rather than using a routine pressure. A way to lower intraabdominal pressure during laparoscopic procedures is to employ a deeper level of neuromuscular blockade.
Intravenous (IV) opioids such as fentanyl and remifentanil are commonly used to provide analgesia and supplement sedation during general anesthesia.
In terms of analgesia, management of intraoperative stress, remifentanil exhibits similar effects to fentanyl in adult healthy volunteers and surgical patients.
In clinical practice, if the surgeon asks for relaxation toward the end of the surgery, then many anesthesiologists will increase the dose of the IV opioids. In our experience the use of remifentanil achieves a better muscle relaxation and surgical space exposure with a lower intraabdominal pressure and less need for a neuromuscular blockage as compared to fentanyl.
Thus, the investigators aimed to compare the use of fentanyl versus remifentanil during laparoscopic hysterectomy. Because surgical complications due to inadequate exposure are a rare event, the typical way to study this issue is to use surgeon's satisfaction score.
Study design- Prospective, single-center single blind randomized controlled trial. Patients electively admitted for laparoscopic hysterectomy will be approached for requirement. After obtaining a written informed consent, patients will be randomly assigned either to the study group (Remifentanil group) or to the control group (Fentanyl group) in a 1:1 ratio. A blocked randomization scheme will be created using a computer-generated list of random numbers.
study protocol-
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REMIFENATIL | Active Comparator | Prospective, single-center single blind randomized controlled trial. Patients electively admitted for laparoscopic hysterectomy will be approached for requirement. After obtaining a written informed consent, patients will be randomly assigned either to the study group (Remifentanil group) or to the control group (Fentanyl group) in a 1:1 ratio. A blocked randomization scheme will be created using a computer-generated list of random numbers. |
|
| FENTANYL | No Intervention | Prospective, single-center single blind randomized controlled trial. Patients electively admitted for laparoscopic hysterectomy will be approached for requirement. After obtaining a written informed consent, patients will be randomly assigned either to the study group (Remifentanil group) or to the control group (Fentanyl group) in a 1:1 ratio. A blocked randomization scheme will be created using a computer-generated list of random numbers. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remifentanil | Drug | Patients electively admitted for laparoscopic hysterectomy will be approached for requirement. After obtaining a written informed consent, patients will be randomly assigned either to the study group (Remifentanil group) or to the control group (Fentanyl group) in a 1:1 ratio. |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical space conditions with modification of a 4-point scale. AT TIME OF COLPOTOMY |
| through study completion, an average of 1 year |
| Surgical space conditions with modification of a 4-point scale. AT THE END OF SURGERY | 1. grade 1 (optimal) = optimal surgical space conditions; | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| surgical space conditions on a numeric rating scale (NRS) | where NRS 0 indicated optimal surgical space conditions and NRS 100 indicated unacceptable surgical space conditions and an intervention is needed to secure acceptable surgical space | through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| MIchal De Wolf | Contact | 9725028346 | michald@wmc.gov.il |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wolfson medical center | Recruiting | Holon | Israel |
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| ID | Term |
|---|---|
| D000077208 | Remifentanil |
| ID | Term |
|---|---|
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |