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OpenTrials
Completed

NCT Number: NCT03818048

Inhaled Sevofluran vs Endovenous Propofol for Colonoscopy

To compare the anesthetic efficacy of the inhalation versus intravenous technique for maintenance of sedation in patients undergoing endoscopy.

A longitudinal, randomized clinical study of 32 patients of both sexes ASA I-III, aged 18-80 years undergoing diagnostic colonoscopy, which was randomly divided into 2 groups. In both, intravenous induction with propofol (2-2.5 mg / kg) was performed, Group A remained sedated with propofol infusion (1-2 mg / kg / min); Group B by inhalation with sevoflurane at a concentration of 2 vol% through a nasal cannula with an oxygen flow.

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Key information

Conditions

Anesthesia

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age between 18 and 80 years
  • physical status I, II and III according to the criteria of the American Society of Anesthesiology (ASA)
  • patients who are going to undergo diagnostic colonoscopies
  • patients who signed the informed consent

Exclusion criteria

  • Allergy or hypersensitivity to some of the reference drugs in the study
  • patients with proven liver disease
  • suspicion or confirmation of pregnancy
  • antecedent or risk of malignant hyperthermia
  • fasting less than 8 hours
  • patients with psychic disorders or mental incapacity that make it difficult to understand their participation in the study
  • patients who have acute illnesses that compromise their health for which the study cannot be performed

Treatment and study plan

Propofol

Drug

after inicial bolus of propofol, remained sedated with propofol infusion (1-2 mg/kg/min)

Sevoflurane

Drug

after inicial bolus of propofol, remained sedated by inhalation with sevoflurane at a concentration of 2 vol% through a nasal cannula with an oxygen flow.

Primary outcomes

  1. Heart rate

    Time frame: During the colonoscopy - an estimated mean time of 20 minutes

    heart rate per minute

  2. The Recovery Time

    Time frame: 30 min

    Every 5 minutes till a score of 10/10 achieved on Aldrete Score

  3. Propofol dosage

    Time frame: During the colonoscopy - an estimated mean time of 20 minutes

    propofol rescate bolus administered

  4. arterial pressure

    Time frame: During the colonoscopy - an estimated mean time of 20 minutes

    non invasive arterial pressure every 5 minutes

  5. oxygen saturation

    Time frame: During the colonoscopy - an estimated mean time of 20 minutes

    pulse oximetry

Secondary outcomes

  1. adverse reactions in patients

    Time frame: 1 day (postoperative)

    desaturation, laryngospasm

  2. Endoscopist Satisfaction

    Time frame: 60 min

    Endoscopist Satisfaction scored from 1-10. Will be tested on a numerical scale from 0 (not satisfied at all) to 10 (fully satisfied)

  3. Qualitatively assess patient comfort after sedation.

    Time frame: Up to 1 hour after completing the study.

    poor, regular or good

Sponsors and collaborators

Lead sponsor

Centro Medico Docente la Trinidad

Other

Registry information

Official study title

Inhaled Sevofluran vs Endovenous Propofol for Sedation Maintenance in Patients Submitted to Colonoscopy

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 28, 2019
Registry last updated
Jan 28, 2019

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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