Ignite Creation Date:
2024-05-06 @ 6:30 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05689242
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-01-19
First Post:
2023-01-08
Brief Title:
Intravenous Nalbuphine Versus Intravenous Dexmedetomidine for Conscious Sedation in Patients Undergoing Colonoscopy
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Comparative Study Between Intravenous Nalbuphine Versus Intravenous Dexmedetomidine for Conscious Sedation in Patients Undergoing Colonoscopy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-01
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:
The aim of this study is to compare the sedative analgesic effect and hemodynamic changes due to dexmedetomidine and nalbuphine during elective colonoscopy
Detailed Description:
Colonoscopy can be performed for the screening of cancer adenomas and polyps for the assessment of known or possible bleeding and for the evaluation of possible causes of abdominal pain gastrointestinal symptoms andor changes in bowel habits colonoscopy is associated with discomfort and sometimes pain At present the commonly used methods are the intravenous injection of propofol etomidate ketamine and other drugs to make the patients unconscious The disadvantage is that the patient cannot cooperate during the examination eg for changing position and medical staff is needed to assist in turning over the patient if necessary This may compress the patients stomach and abdomen which may cause gastric reflux and aspiration which may cause pneumonia with morbidity and even mortality Nalbuphine hydrochloride is a mixed agonist-antagonist opioid with a duration of action of approximately 3-6 hours It is chemically related to both the agonist analgesic oxymorphone and the antagonist naloxone and acts as an antagonist at the μ receptor and as an agonist at the κ receptor resulting in analgesia and sedation with minimal effects in the cardiovascular system Any slight RD that occurs would be restricted by a ceiling effect Dexmedetomidine a new drug is highly selective α2-adrenergic receptor agonist It possesses hypnotic sedative anxiolytic sympatholytic and analgesic properties without producing significant respiratory depression It also reduces both anesthetic and opioid analgesic requirements during the perioperative period It has an impressive safety marginand it may be suitable for conscious sedation during painful procedures
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