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NCT Number: NCT06507410

Additive Effects of Clonidine Used in Propofol Sedation in Colonoscopy

The objective of this study was to compare safety, satisfaction, and efficiency outcomes of propofol versus propofol with clonidine in patients undergoing colonoscopy.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Colonoscopy is one of the most common procedures in the world, Colonoscopy is a procedure often performed for prevention, diagnosis, and treatment of a variety of symptoms and diseases of the lower digestive tract, and sedation or anesthesia should be considered as an important tool to increase its effectiveness.

Sedation and analgesia are considered key components, as they reduce anxiety and discomfort and therefore improve the procedure tolerability and patient satisfaction, minimize risk of complications and provide better conditions for the examination.

Propofol may be used alone or in combination with opioids and/or benzodiazepines.

The use of propofol alone requires higher doses, which may lead to increased incidence of side effects. However, the risks and benefits of adding analgesic and sedative to propofol are controversial, and the selection of drugs is a crucial factor in determining the outcomes.

Clonidine apparently produces its sedative and anaesthetic-sparing effects by stimulation of centrally located alpha2 adrenoceptors. Analgesia seems to be mediated mainly by activation of alpha2 adrenoceptors in the dorsal horn of the spinal cord.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-65 years.
  • Both sexes.
  • American Society of Anesthesiology (ASA) physical status I-II.
  • Patients undergoing colonoscopy.

Exclusion criteria

  • Patients had recent history of colonoscopy.
  • Previous colonic resection.
  • Severe heart failure (ejection fraction < 30%).
  • Known history of hypersensitivity to propofol or clonidine and any need for anesthetic drug administration other than the study protocol.

Treatment and study plan

Propofol

Drug

Continuous propofol infusion will be given with syringe pump for maintenance, with the initial rate set at 25-75 mic/kg/min IV during the first 10-15 min. To avoid administering sedatives at rates greater than clinically necessary, infusion rates will be gradually titrated to 25-50 mic/kg/min and regulated with the clinical response, with an onset of peak drug action expected to occur within 2 min.

Propofol combined with clonidine

Drug

Patients will receive 2 μg/kg of clonidine for injection intravenously 30 min before induction of sedation, administered over 10 min.

Primary outcomes

  1. Patient satisfaction

    Time frame: 24 hours postoperatively

    Patient's satisfaction level will be assessed with a Likert five-item scoring system (1 = Not at all satisfied, 2 = slightly satisfied, 3 = somewhat satisfied, 4 = very satisfied, and 5 = extremely satisfied).

Secondary outcomes

  1. Heart rate

    Time frame: Till the end of surgery

    Heart rate will be recorded at 30 minutes before induction, at induction, and at the end of surgery.

  2. Mean arterial blood pressure

    Time frame: Till the end of surgery

    Mean arterial blood pressure will be recorded at 30 minutes before induction, at induction, and at the end of surgery.

  3. Side effects

    Time frame: 24 hours postoperatively

    Side effects such as nausea and vomiting, psychological reactions will be noted.

Study contacts

Contact information is provided by the study sponsor or research team.

Rabab M Mohamed, MD

CONTACT

[email protected]

00201069122935

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 18, 2024
Registry last updated
Jul 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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