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

Sponsor

Assiut University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05689242

Collaborator

(none)

Enrollment

Arms

21.1

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colonoscopy	Drug: Dexmedetomidine Injection [Precedex]	Phase 4

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, 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

66 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group I 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] intravenous dexmedetomidine for group I and nalubphine for group II in colposcopy Other Names: nalbuphine
Experimental: Group II 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] intravenous dexmedetomidine for group I and nalubphine for group II in colposcopy Other Names: nalbuphine

Arm

Intervention/Treatment

Experimental: Group I

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]

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

Other Names:

nalbuphine

Experimental: Group II

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]

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

Other Names:

nalbuphine

Outcome Measures

Primary Outcome Measures

variable is to compare the sedation effect between Nalbuphine and Dexmedetomidine. [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.]
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

Secondary Outcome Measures

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.]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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.