Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06231992 |
| Other study ID # |
Anesthesia for cholecystectomy |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 31, 2024 |
| Est. completion date |
July 2024 |
Study information
| Verified date |
January 2024 |
| Source |
Al-Azhar University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The aim of this study is to compare the efficacy of Opioid-free anesthesia (OFA) with opioid
anaesthesia (OA) in patients undergoing laparoscopic cholecystectomy (LC).
Description:
Laparoscopic Cholecystectomy (LC) is a standard surgical procedure for cholelithiasis and
gallstone disease, became rapidly the procedure of choice for gallbladder disease and It
decreases postoperative pain, decreases the need for postoperative analgesia, shortens the
hospital stay, and returns the patient to full activity within 1 week (compared with 1 month
after open cholecystectomy). LC also provides less scars and improved patient satisfaction as
compared with open cholecystectomy Pneumoperitoneum is created using Carbon dioxide, and a
camera and dissecting instruments are introduced in the abdominal cavity. Initiation and
maintenance of pneumoperitoneum cause hemodynamic stress, which is attenuated by adequate
anesthesia depth and often multimodal analgesia. Although laparoscopic cholecystectomy is a
standard minimally invasive surgical procedure, some patients may have significant morbidity
in the first 24 to 72 hours during the postoperative period Opioids are commonly used for
intraoperative analgesia and sedation during general anesthesia and are among the most widely
used agents for treating acute pain in the immediate postoperative period. Opioids are known
to provide adequate analgesia and stable intraoperative hemodynamics, which are the most
critical concerns during the perioperative period. Although opioids are an essential
constituent of balanced anesthesia, their use has been questioned due to severe and
significant adverse effects Moreover, the availability of potent opioids in low-resource
settings is also a remarkable challenge. To tackle this situation several suitable
alternatives were explored. Preemptive and multimodal analgesia is an established care model
that minimizes perioperative opioid consumption, thereby minimizing adverse effects and
promoting positive outcomes after surgery These techniques combine the pharmacologic effects
of multiple analgesics to achieve a synergistic effect of their different modes of action and
curtail individual drug doses, thereby minimizing their side effects, Opioid-free anesthesia
(OFA) Sympathetic and parasympathetic suppression can be achieved today with loco-regional
anaesthesia or by several non-opioid drugs. Opioid free general anaesthesia can be achieved
with 50 mg ketamine given after propofol and before incision in spontaneous breathing
patients like for plastic surgery .The alpha-2agonists , suppress better the sympathetic
system and can replace opioids for sympathetic stabilization in major surgery
