Sedation With Dexmedetomidine Versus Remifentanil in Urogynecological Surgery Under Spinal Anaesthesia

• Status: Recruiting
• Trial end date: 2022-04-20
• Target enrollment: 0
• Participant gender: Female

Summary

Neuraxial blocks are usually used as an anaesthetic method for urogynecological surgeries. In most patients under regional anaesthesia, premedication is given for reducing anxiety. Purpose of this prospective double blind randomised clinical trial is the investigation of the effect of perioperative intravenous infusion of dexmedetomidine vs remifentanil for sedation in patients under spinal anaesthesia for urogynecological procedures.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Athens
• Treatments: Anesthetics; Dexmedetomidine; Remifentanil

Criteria

Inclusion Criteria:

• Physical status according to American Society of Anesthesiologists (ASA) I-II

• Patients scheduled for transvaginal urogynecological or gynecological surgery

Exclusion Criteria:

• Patient refusal

• Contraindication of spinal anaesthesia (Coagulopathy, Local infection at the site of injection, Local anaesthetic allergy, Hypovolaemia)

• BMI > 30 kg/m2

• Personal history of cardiovascular disease

• Arrythmias

• Conduction disorders

• Severe kidney or liver dysfunction

• Insulin-dependent diabetes mellitus

• Central nervous system disorders

• Psychiatric and mental status disorders

• Chronic Excessive Alcohol Consumption

• Chronic Use of Opioid Analgesics

• Chronic Use of corticosteroids

• Chronic Use of clonidine (or other a2 adrenergic agonist)

• Use of drugs acting on central nervous system or analgetics the last two weeks

• Communication problems due to language barriers or unable to understand the pain scale