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Sedation using Ketofol versus Fentanyl + Propofol in patients undergoing Lower Gastrointestinal Endoscopy: a randomized trial

Ketofol versus Fentanyl + Propofol for sadation in patients submitted to Colonoscopy: a randomized study

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
REBEC
Registry ID
RBR-4mvny8s
Enrollment
Unknown
Registered
2023-08-26
Start date
2022-07-01
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Analgesia

Interventions

This is a prospective, experimental, interventional, controlling, randomized and single blind study. The research will be carried out in a high complexity private hospital in São Luís do Maranhão. The
active bleeding
American Society of Anesthesiologists III, IV or V
history of hypersensitivity to drugs used in research
epilepsy
cardiac function functioning
severe surgery study
altered intracranial pressure or hemodynamic instability such as peripheral pressure 90%
systolic blood pressure 60mmHg and heart rate = 40 beats per minute. The sample size was calculations with an assumption of a possible difference of at least 30% in between the two groups. Therefore,
D27.505.696.277.350

Sponsors

Hospital São Domingos
Lead Sponsor
Hospital São Domingos
Collaborator

Eligibility

Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: After approval by the Research Ethics Committee of the Hospital and the Free and Informed Consent Term (APPENDIX C) signed, patients aged 18 to 65 years, ASA I-II, undergoing elective colonoscopy in a private hospital in São Luís - MA.

Exclusion criteria

Exclusion criteria: Patients who refuse to participate or who have: pregnancy, active gastrointestinal bleeding, ASA III-V, history of hypersensitivity to the drugs used in this research, epilepsy, severe heart failure, severe respiratory failure, increased intracranial pressure and /or hemodynamic instability such as peripheral oxygen saturation = 90%, systolic blood pressure (SBP) < 60 mmHg and heart rate = 40 bpm.

Design outcomes

Primary

MeasureTime frame
It is expected to find the best sedation scheme for coloscopy procedures through the method of comparing two proposed sedation schemes. Anesthesia time in minutes recorded as described above (before, during and after sedation) will be analyzed. Efficacy, safety and recovery time will be observed allowing at least a 5% variation in measurements before and after the intervention.;It is expected to find the best sedation scheme for coloscopy procedures through the method of comparing two proposed sedation schemes. Procedure time in minutes recorded as described above (before, during and after sedation) will be analyzed. Efficacy, safety and recovery time will be observed allowing at least a 5% variation in measurements before and after the intervention.;It is expected to find the best sedation scheme for coloscopy procedures through the method of comparing two proposed sedation schemes. Mean Arterial Pressure recorded as previously described (before, during and after sedation) will be analyzed. Efficacy, safety and recovery time will be observed allowing at least a 5% variation in measurements before and after the intervention.;It is expected to find the best sedation scheme for coloscopy procedures through the method of comparing two proposed sedation schemes. Heart rate will be analyzed in beats per minute recorded as described above (before, during and after sedation). Efficacy, safety and recovery time will be observed allowing at least a 5% variation in measurements before and after the intervention.;It is expected to find the best sedation scheme for coloscopy procedures through the method of comparing two proposed sedation schemes. Respiratory rate will be analyzed in breaths per minute recorded as described above (before, during and after sedation). Efficacy, safety and recovery time will be observed allowing at least a 5% variation in measurements before and after the intervention.;It is expected to find the best sedation scheme for coloscopy procedures throug

Secondary

MeasureTime frame
It is expected to find the best sedation scheme for coloscopy procedures through the method of comparing two proposed sedation schemes. Hemodynamic stability will be analyzed. The results will be observed and a variation of at least 5% in the measurements before and after the intervention will be allowed.;It is expected to find the best sedation scheme for coloscopy procedures through the method of comparing two proposed sedation schemes. Respiratory safety will be analyzed. The results will be observed and a variation of at least 5% in the measurements before and after the intervention will be allowed.;It is expected to find the best sedation scheme for coloscopy procedures through the method of comparing two proposed sedation schemes. Adverse effects will be analyzed. The results will be observed and a variation of at least 5% in the measurements before and after the intervention will be allowed.;It is expected to find the best sedation scheme for coloscopy procedures through the method of comparing two proposed sedation schemes. The duration of recovery from surgery will be analyzed. The results will be observed and a variation of at least 5% in the measurements before and after the intervention will be allowed.;It is expected to find the best sedation scheme for coloscopy procedures through the method of comparing two proposed sedation schemes. Pain control will be analyzed. The results will be observed and a variation of at least 5% in the measurements before and after the intervention will be allowed.;It is expected to find the best sedation scheme for coloscopy procedures through the method of comparing two proposed sedation schemes. Will be analyzed and satisfaction of patients and anesthesiologists with the procedure. The results will be observed and a variation of at least 5% in the measurements before and after the intervention will be allowed.

Countries

Brazil

Contacts

Public ContactPlínio Leal

Hospital São Domingos

pliniocunhaleal@hotmail.com+55 (98) 988522021

Outcome results

None listed

Source: REBEC (via WHO ICTRP)