Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06355687
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-09
First Post:
2024-03-10
Brief Title:
Melatonin in Obese Patients in Laparoscopic Cholecystectomy
Sponsor:
Ain Shams University
Organization:
Ain Shams University
Study Overview
Official Title:
The Evaluation of Adding Melatonin to Opioid Free Anesthesia on Postoperative Pain in Obese Patients Undergoing Laparoscopic Cholecystectomy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Opioid free anesthesia OFA means a technique in which no intraoperative opioid is administered through any route Perioperative pain management in an obese patient is challenging The incidence of respiratory depression is higher in obese patients and is exaggerated with opioids so the investigators are searching for a drug that has analgesic effect without any effect on respiratory function In this study the investigators will add melatonin to OFA in obese patients undergoing laparoscopic cholecystectomy
Detailed Description:
Obesity leads to a restrictive lung disease causing reduction in functional residual capacity and total lung compliance
When an obese patient is supine and anesthetised the depressant effects of many anesthetic agents and analgesics particularly opioids further decrease the lung compliance leading to increased hypoxemia
Opioid based general anesthesia in these patients increases the incidence of postoperative respiratory depression atelectasis and pneumonia Also pain relief with opioids is associated with sedation hence impeding rapid recovery and early mobilization
OFA is the use of multimodal or balanced analgesia The principle of this is to gain additive analgesic effects from different drugs while minimizing side effects particularly those of opioids Studies have shown that OFA fast tracks surgery reduces hospital stay promotes early mobilization and enteral nutrition
Prior studies which investigated opioid free techniques are based on the combination of drugs acting on sympathetic nervous system perioperative administration of local anesthetics nonsteroidal anti-inflammatory drugs and of adjuvant drugs such as ketamine magnesium etc
Laparoscopic surgery is more challenging in obese patients since they have excessive pneumoperitoneal insufflation pressures longer anesthetic surgical and recovery times Moreover these procedures are usually done in Trendelenburg position which further leads to increased airway resistance
Melatonin is mainly secreted from the pineal gland by the suprachiasmatic nucleus This neurohormone possesses a circadian secretion pattern and regulates the biological clock it also offers antiemetic analgesic and anxiolytic effects Due to its effect on both acute and chronic pain melatonin fulfills a beneficial role in reducing postoperative opioid consumption while minimizing nausea and vomiting In addition melatonin can be used to moderate the effect of light on the autonomic system
Several studies have reported that melatonin as an analgesic anti-inflammatory anxiolytic and anti-agitation premedication is associated with sedation and anxiolysis without adverse effects on recall and driving performance
When an obese patient is supine and anesthetised the depressant effects of many anesthetic agents and analgesics particularly opioids further decrease the lung compliance leading to increased hypoxemia
Opioid based general anesthesia in these patients increases the incidence of postoperative respiratory depression atelectasis and pneumonia Also pain relief with opioids is associated with sedation hence impeding rapid recovery and early mobilization
OFA is the use of multimodal or balanced analgesia The principle of this is to gain additive analgesic effects from different drugs while minimizing side effects particularly those of opioids Studies have shown that OFA fast tracks surgery reduces hospital stay promotes early mobilization and enteral nutrition
Prior studies which investigated opioid free techniques are based on the combination of drugs acting on sympathetic nervous system perioperative administration of local anesthetics nonsteroidal anti-inflammatory drugs and of adjuvant drugs such as ketamine magnesium etc
Laparoscopic surgery is more challenging in obese patients since they have excessive pneumoperitoneal insufflation pressures longer anesthetic surgical and recovery times Moreover these procedures are usually done in Trendelenburg position which further leads to increased airway resistance
Melatonin is mainly secreted from the pineal gland by the suprachiasmatic nucleus This neurohormone possesses a circadian secretion pattern and regulates the biological clock it also offers antiemetic analgesic and anxiolytic effects Due to its effect on both acute and chronic pain melatonin fulfills a beneficial role in reducing postoperative opioid consumption while minimizing nausea and vomiting In addition melatonin can be used to moderate the effect of light on the autonomic system
Several studies have reported that melatonin as an analgesic anti-inflammatory anxiolytic and anti-agitation premedication is associated with sedation and anxiolysis without adverse effects on recall and driving performance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None