NCT05689242

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 19, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

January 19, 2023

Status Verified

January 1, 2023

Enrollment Period

1 year

First QC Date

January 8, 2023

Last Update Submit

January 17, 2023

Conditions

Colonoscopy

Keywords

DexmedetomidinenalbuphinecolonoscopyConscious Sedation

Outcome Measures

Primary Outcomes (1)

  • 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. 1. Patient is anxious and agitated or restless, or both. 2. Patient is cooperative, oriented and tranquil. 3. Patient responds to commands only. 4. Patient exhibits brisk response to light glabellar tap or loud auditory stimulus. 5. Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus. 6. 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 Outcomes (1)

  • variables are the hemodynamic comparison, pain score assessment and adverse event among two groups.

    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.

Study Arms (2)

Group I

EXPERIMENTAL

Receive initial loading dose of (Dexmedetomidine 1 μg/kg I.V) diluted up to 10 ml with normal saline infused over 10 min, followed by a continuous infusion of 0.2-0.8 μg/kg/h through a 50 ml syringe and an electronic infusion pump

Drug: Dexmedetomidine Injection [Precedex]

Group II

EXPERIMENTAL

Receive (Nalbuphine 0.1 to 0.2 mg/kg I.V) diluted up to 10 ml with normal saline infused slowly over 10 min.

Drug: Dexmedetomidine Injection [Precedex]

Interventions

Dexmedetomidine Injection [Precedex]DRUG

intravenous dexmedetomidine for group I and nalubphine for group II in colposcopy

Also known as: nalbuphine
Group IGroup II

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The subject is scheduled for elective colonoscopy.
  • The subject is ≥ 18 years and ≤ 80 years.
  • Both sexes.
  • No obvious abnormalities in preoperative ECG, blood routine ,electrolytes, and other tests .
  • ASA class 1-3.

You may not qualify if:

  • Subject is known or believed to be pregnant or lactating women.
  • Patients allergic to α2-adrenergic agonist or sulfa drugs
  • Chronic Opioid Use (daily or almost daily use of opioids for \> 3 months).
  • Patients that are immunologically compromised, or receiving chronic steroids (\>30 days), excluding inhalers.
  • Sleep apnea syndrome or difficult airway.
  • Patient known to be asthmatic or recent chest infection.
  • Patients that are prisoners.
  • Patient refusal.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • 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.

    PMID: 15017641BACKGROUND

  • 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.

    PMID: 18291396BACKGROUND

  • 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.

    PMID: 18165564BACKGROUND

  • 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.

    PMID: 29628562BACKGROUND

  • 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.

    PMID: 19713256BACKGROUND

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

    PMID: 1026900BACKGROUND

  • Abdelrady MM, Yousef HA, Khalaf KA, Abulfadl OA, Hassanien MH. Comparative study between nalbuphine and dexmedetomidine for conscious sedation in patients undergoing colonoscopy: randomized comparative trial. BMC Anesthesiol. 2025 Nov 28;25(1):603. doi: 10.1186/s12871-025-03482-4.

    PMID: 41310459DERIVED

MeSH Terms

Interventions

DexmedetomidineNalbuphine

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Central Study Contacts

omar AB abulfadl, bachelor's

CONTACT

0021069909234omarabulfadl1@gmail.com

hamdy youssef, prof

CONTACT

0021090008490hamdyayoussef@yahoo.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
OTHER
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
omar abdelaziz abulfadl abdelaziz

Study Record Dates

First Submitted

January 8, 2023

First Posted

January 19, 2023

Study Start

March 1, 2023

Primary Completion

March 1, 2024

Study Completion

December 1, 2024

Last Updated

January 19, 2023

Record last verified: 2023-01