Dexmedetomidine vs. Remifentanil Undergoing Cataract Surgery in Geriatrics

NCT ID: NCT04935541

Last Updated: 2021-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2010-07-31

Brief Summary

Dexmedetomidine is an α2-adrenergic receptor agonist used for its sympatholytic effect, providing sedation, analgesia, and cardiovascular stabilization in the perioperative period. Remifentanil is a µ opioid agonist with a rapid onset and short duration of action, which is degraded by plasma esterase in tissues. Investigators aimed to compare the effects of dexmedetomidine and remifentanil infusions on sedation quality, side effects, and surgeon's satisfaction in geriatric outpatients who underwent cataract surgery.

Detailed Description

Dexmedetomidine is an α2 agonist and remifentanil is a short-acting μ, opioid agonist. The aim of this study was to compare dexmedetomidine and remifentanil infusions used for conscious sedation in geriatric patients undergoing outpatient cataract surgery in terms of sedation quality, hemodynamic stability, and surgeon satisfaction.

Eighty patients were divided into two groups according to the administration of dexmedetomidine (Group D) and remifentanil (Group R) infusion in this randomized, prospective, double-blinded study. In group D (n = 40), after a loading of 1 µg/kg dexmedetomidine in 10 minutes, 0.4 µg/kg/h-1 infusion was administered. In Group R (n = 40), remifentanil at a dose of 0.05 µg/kg-1 was administered for 10 minutes, and then 0.05 µg/kg/min-1 infusion was continued.

Conditions

Geriatrics; Outpatients; Personal Satisfaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Dexmedetomidine infusion

Dexmedetomidine (Precedex, Meditera, USA) was administered at a loading dose of 1 µg/kg for 10 minutes before local anesthesia to be applied to the eye by the surgeon. During the surgical procedure, it was administered at a dose of 0.4 µg/kg/h-1 infusion.

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine infusion

Intervention Type: DRUG

After Dexmedetomidine infusion was given for 10 minutes, local anesthesia was applied by the surgeon. Peribulbar block and periorbital infiltration application were performed by applying a mixture of lidocaine (Jetokain, Adeka, Turkey) and 1/200000 adrenaline. After the local anesthetic agent was applied by the surgeon, orbital compression was provided for 5 minutes with maximum pressure to block the eyelid movements. Cataract surgery procedures of all patients included in the study were performed by the same surgeon.

Remifentanil infusion

Remifentanil (Ultiva, Glaxo SmithKline, Turkey) infusion was started at a dose of 0.05 µg/kg/min-1, 10 minutes before the start of the surgery as baseline infusion and continued at the same infusion dose throughout the surgical procedure.

Group Type: ACTIVE_COMPARATOR

Remifentanil infusion

Intervention Type: DRUG

After Remifentanil infusion was given for 10 minutes, local anesthesia was applied by the surgeon. Peribulbar block and periorbital infiltration application were performed by applying a mixture of lidocaine (Jetokain, Adeka, Turkey) and 1/200000 adrenaline. After the local anesthetic agent was applied by the surgeon, orbital compression was provided for 5 minutes with maximum pressure to block the eyelid movements. Cataract surgery procedures of all patients included in the study were performed by the same surgeon.

Interventions

Dexmedetomidine infusion

After Dexmedetomidine infusion was given for 10 minutes, local anesthesia was applied by the surgeon. Peribulbar block and periorbital infiltration application were performed by applying a mixture of lidocaine (Jetokain, Adeka, Turkey) and 1/200000 adrenaline. After the local anesthetic agent was applied by the surgeon, orbital compression was provided for 5 minutes with maximum pressure to block the eyelid movements. Cataract surgery procedures of all patients included in the study were performed by the same surgeon.

Intervention Type: DRUG

Remifentanil infusion

After Remifentanil infusion was given for 10 minutes, local anesthesia was applied by the surgeon. Peribulbar block and periorbital infiltration application were performed by applying a mixture of lidocaine (Jetokain, Adeka, Turkey) and 1/200000 adrenaline. After the local anesthetic agent was applied by the surgeon, orbital compression was provided for 5 minutes with maximum pressure to block the eyelid movements. Cataract surgery procedures of all patients included in the study were performed by the same surgeon.

Intervention Type: DRUG

Other Intervention Names

Cataract surgery; Cataract surgery

Eligibility Criteria

Inclusion Criteria

• Patients between the ages of 65-80,
• Who will undergo cataract surgery,
• With the American Society of Anesthesiologists (ASA) score I-III.

Exclusion Criteria

• Second or third-degree heart block,
• Chronic α2-agonist use,
• Inability to communicate with the patient,
• Uncontrolled systemic disease,
• Allergy to local anesthetics,
• Chronic analgesic or sedative drug use,
• History of alcohol or substance addiction.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hacettepe University

OTHER

Sponsor Role: collaborator

Selcuk University

OTHER

Sponsor Role: lead

Responsible Party

Ozkan Onal

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nalan Celebi, Professor

Role: STUDY_CHAIR

Hacettepe University

Locations

Hacettepe University

Ankara, Sıhhiye, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Kumar CM, Seet E, Eke T, Irwin MG, Joshi GP. Peri-operative considerations for sedation-analgesia during cataract surgery: a narrative review. Anaesthesia. 2019 Dec;74(12):1601-1610. doi: 10.1111/anae.14845. Epub 2019 Sep 19.

Reference Type: BACKGROUND

PMID: 31535721 (View on PubMed)

Other Identifiers

HEK 09/59-19

Identifier Type: -

Identifier Source: org_study_id