Reduces intravenous lidocaine the need for alfentanyl during colonoscopy under Procedural Sedation and Analgesia?

Study: Reduces intravenous lidocaine the need for alfentanyl during colonoscopy under Procedural Sedation and Analgesia?

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002210-46-NL

Enrollment

Registered

2016-07-28

Start date

2016-07-28

Completion date

Unknown

Last updated

2020-11-09

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

Conditions

patients with IBD, between 18 and 65 years, which are scheduled for a colonoscopy with PSA.

Interventions

Trade Name: Lidocaïnehydrochloride 10 mg/ml Product Name: Lidocaine Product Code: RVG 51673 Pharmaceutical Form: Infusion Pharmaceutical form of the placebo: Infusion Route of administration of the pl

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Colonoscopy performed under PSA Age 18-65 years Inflammatory bowel disease: Crohn’s disease or ulcerative colitis Informed consent ASA classification 1 or 2 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 76 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 76

Exclusion criteria

Exclusion criteria: Pregnancy. Emergency colonoscopy. Known allergies for study medication Known rhythm disorders i.e. second or third degree AV block BMI >35 Obstructive sleep apnea syndrome Uncontrolled hypertension

Design outcomes

Primary

Measure	Time frame
Main Objective: te evaluate whether continuous infusion of lidocaïne reduces the need for alfentanyl in diagnostic colonoscopy in patients with Crohn disease or ulcerative colitis.;Secondary Objective: To evaluate the differences in side effects like respiratory depression, hypotension, postoperative nausea and vomiting (PONV) and post procedural pain between placebo and intravenous lidocaïne. ;Primary end point(s): The primary objective of this study is to evaluate whether intravenously lidocaine reduces the need for alfentanyl during colonoscopy in patients with IBD;Timepoint(s) of evaluation of this end point: postprocedural	—

Measure

Time frame

Main Objective: te evaluate whether continuous infusion of lidocaïne reduces the need for alfentanyl in diagnostic colonoscopy in patients with Crohn disease or ulcerative colitis.;Secondary Objective: To evaluate the differences in side effects like respiratory depression, hypotension, postoperative nausea and vomiting (PONV) and post procedural pain between placebo and intravenous lidocaïne. ;Primary end point(s): The primary objective of this study is to evaluate whether intravenously lidocaine reduces the need for alfentanyl during colonoscopy in patients with IBD;Timepoint(s) of evaluation of this end point: postprocedural

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Secondary

Measure	Time frame
Secondary end point(s): Incidence of hypotension (a mean arterial pressure (MAP < 60 mmHg), is recorded as an adverse event if an intervention is performed to improve the blood pressure. These interventions include administration of: - IV Fluid challenge - Medications Incidence of oxygen desaturation (<92%), is recorded as an adverse event if an intervention is performed to improve the oxygen saturation. These interventions include the following: - Vigorous tactile stimulation - Airway repositioning - Suctioning - Increased oxygen delivery - Oral or nasal airway placement - Application of positive pressure or ventilation with bag mask Incidence of unpleasant recall of the procedure. Postprocedural NRS Incidence of PONV Incidence of adverse effects of lidocaine: light headedness, tinnitus, dizziness, blurred vision or double vision, metal taste. Total propofol dose Colonoscopy time ;Timepoint(s) of evaluation of this end point: postprocedural	—

Measure

Time frame

Secondary end point(s): Incidence of hypotension (a mean arterial pressure (MAP < 60 mmHg), is recorded as an adverse event if an intervention is performed to improve the blood pressure. These interventions include administration of: - IV Fluid challenge - Medications Incidence of oxygen desaturation (<92%), is recorded as an adverse event if an intervention is performed to improve the oxygen saturation. These interventions include the following: - Vigorous tactile stimulation - Airway repositioning - Suctioning - Increased oxygen delivery - Oral or nasal airway placement - Application of positive pressure or ventilation with bag mask Incidence of unpleasant recall of the procedure. Postprocedural NRS Incidence of PONV Incidence of adverse effects of lidocaine: light headedness, tinnitus, dizziness, blurred vision or double vision, metal taste. Total propofol dose Colonoscopy time ;Timepoint(s) of evaluation of this end point: postprocedural

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Countries

Netherlands

Contacts

Public ContactTwan Aalbers

RadboudUMC

twan.aalbers@radboudumc.nl0031243614406

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026