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Inhaled Sevofluran vs Endovenous Propofol for Colonoscopy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03818048
Enrollment
32
Registered
2019-01-28
Start date
2016-01-01
Completion date
2016-12-28
Last updated
2019-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Keywords

sedation, colonoscopy

Brief summary

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.

Interventions

DRUGPropofol

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

DRUGSevoflurane

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.

Sponsors

Centro Medico Docente la Trinidad
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
oxygen saturationDuring the colonoscopy - an estimated mean time of 20 minutespulse oximetry
The Recovery Time30 minEvery 5 minutes till a score of 10/10 achieved on Aldrete Score
Propofol dosageDuring the colonoscopy - an estimated mean time of 20 minutespropofol rescate bolus administered
arterial pressureDuring the colonoscopy - an estimated mean time of 20 minutesnon invasive arterial pressure every 5 minutes
Heart rateDuring the colonoscopy - an estimated mean time of 20 minutesheart rate per minute

Secondary

MeasureTime frameDescription
Endoscopist Satisfaction60 minEndoscopist Satisfaction scored from 1-10. Will be tested on a numerical scale from 0 (not satisfied at all) to 10 (fully satisfied)
Qualitatively assess patient comfort after sedation.Up to 1 hour after completing the study.poor, regular or good
adverse reactions in patients1 day (postoperative)desaturation, laryngospasm

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026