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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-31

Study Completion Date

2024-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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

Group Type EXPERIMENTAL

Dexmedetomidine Injection [Precedex]

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

Dexmedetomidine Injection [Precedex]

Intervention Type DRUG

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

Interventions

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Dexmedetomidine Injection [Precedex]

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

Intervention Type DRUG

Other Intervention Names

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nalbuphine

Eligibility Criteria

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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 α2-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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No