Intravenous Nalbuphine Versus Intravenous Dexmedetomidine for Conscious Sedation in Patients Undergoing Colonoscopy

Colonoscopy Clinical Trial

Official title:

Comparative Study Between Intravenous Nalbuphine Versus Intravenous Dexmedetomidine for Conscious Sedation in Patients Undergoing Colonoscopy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05689242
• Other study ID #: sedation in Colonoscopy
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: March 2023
• Est. completion date: December 2024

Study information

• Verified date: January 2023
• Source: Assiut University
• Contact: omar AB abulfadl, bachelor's
• Phone: 0021069909234
• Email: omarabulfadl1[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to compare the sedative, analgesic effect and hemodynamic changes due to dexmedetomidine and nalbuphine during elective colonoscopy.

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, and/or 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 patient's unconscious. The disadvantage is that the patient cannot cooperate during the examination (e.g., for changing position), and medical staff is needed to assist in turning over the patient, if necessary. This may compress the patient's 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 margin,and it may be suitable for conscious sedation during painful procedures.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 66
• Est. completion date: December 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. The subject is scheduled for elective colonoscopy.

2. The subject is = 18 years and = 80 years.

3. Both sexes.

4. No obvious abnormalities in preoperative ECG, blood routine ,electrolytes, and other tests .

5. ASA class 1-3.

Exclusion Criteria:

1. Subject is known or believed to be pregnant or lactating women.

2. Patients allergic to a2-adrenergic agonist or sulfa drugs

3. Chronic Opioid Use (daily or almost daily use of opioids for > 3 months).

4. Patients that are immunologically compromised, or receiving chronic steroids (>30 days), excluding inhalers.

5. Sleep apnea syndrome or difficult airway.

6. Patient known to be asthmatic or recent chest infection.

7. Patients that are prisoners.

8. Patient refusal.

Related Conditions & MeSH terms

• Colonoscopy

Intervention

Drug:
• Dexmedetomidine Injection [Precedex]
intravenous dexmedetomidine for group I and nalubphine for group II in colposcopy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (6)

Candiotti KA, Bergese SD, Bokesch PM, Feldman MA, Wisemandle W, Bekker AY; MAC Study Group. Monitored anesthesia care with dexmedetomidine: a prospective, randomized, double-blind, multicenter trial. Anesth Analg. 2010 Jan 1;110(1):47-56. doi: 10.1213/ane.0b013e3181ae0856. Epub 2009 Aug 27. — View Citation

Karanth H, Murali S, Koteshwar R, Shetty V, Adappa K. Comparative Study between Propofol and Dexmedetomidine for Conscious Sedation in Patients Undergoing Outpatient Colonoscopy. Anesth Essays Res. 2018 Jan-Mar;12(1):98-102. doi: 10.4103/aer.AER_206_17. — View Citation

Kaygusuz K, Gokce G, Gursoy S, Ayan S, Mimaroglu C, Gultekin Y. A comparison of sedation with dexmedetomidine or propofol during shockwave lithotripsy: a randomized controlled trial. Anesth Analg. 2008 Jan;106(1):114-9, table of contents. doi: 10.1213/01.ane.0000296453.75494.64. — View Citation

Muller S, Borowics SM, Fortis EA, Stefani LC, Soares G, Maguilnik I, Breyer HP, Hidalgo MP, Caumo W. Clinical efficacy of dexmedetomidine alone is less than propofol for conscious sedation during ERCP. Gastrointest Endosc. 2008 Apr;67(4):651-9. doi: 10.1016/j.gie.2007.09.041. Epub 2008 Mar 4. — View Citation

Scott J, Huskisson EC. Graphic representation of pain. Pain. 1976 Jun;2(2):175-84. No abstract available. — View Citation

Ulmer BJ, Hansen JJ, Overley CA, Symms MR, Chadalawada V, Liangpunsakul S, Strahl E, Mendel AM, Rex DK. Propofol versus midazolam/fentanyl for outpatient colonoscopy: administration by nurses supervised by endoscopists. Clin Gastroenterol Hepatol. 2003 Nov;1(6):425-32. doi: 10.1016/s1542-3565(03)00226-x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	variable is to compare the sedation effect between Nalbuphine and Dexmedetomidine.	3- Sedation score: sedation will be monitored immediately after examination, at PACU admission, and 30 min after procedure by Ramsay Sedation Scale (RSS; 1974) The RSS scores sedation at six different levels, according to how rousable the patient is.; Patient is anxious and agitated or restless, or both.; Patient is cooperative, oriented and tranquil.; Patient responds to commands only.; Patient exhibits brisk response to light glabellar tap or loud auditory stimulus.; Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus.; Patient exhibits no response	before the study drug administration (baseline), after the study drug administration ,Then every 5min till the examination ends,at PACU admission, and 30 min after procedure.
Secondary	variables are the hemodynamic comparison, pain score assessment and adverse event among two groups.	4- Pain score: Intensity of pain will be monitored immediately after examination, at PACU admission, and 30 min after procedure by visual analogue score (VAS),The (VAS) consist of 10cm line, with to end points representing 0 (no pain) and 10 (pain as bad as it possibly be), ask the patient to rete their current level of pain by placing a mark on the line, by using a ruler to measure the distance from 0 (no pain point) to the current pain mark	before the study drug administration (baseline), after the study drug administration ,Then every 5min till the examination ends,at PACU admission, and 30 min after procedure.