Dexmedetomidine vs. Remifentanil Undergoing Cataract Surgery in Geriatrics

NCT04935541 | Completed

• 1 other identifier: HEK 09/59-19
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Geriatrics; Outpatients; Personal Satisfaction

Keywords

geriatrics; ambulatory surgery; cataract; anesthesia; conscious sedation; dexmedetomidine; remifentanil

Outcome Measures

Primary Outcomes (3)

• Sedation quality

  The Observer Assessment Warning/Sedation Scale (OAA/S) was used to determine the sedation quality of each patient. The minimum and maximum values of OAA/S scale was between 0 and 5. Lower scores mean a better sedation quality.

  Time interval immediately after the start of the surgery and before the patient is transferred to the postoperative care unit.

• Sedation level

  Bispectral Index (BIS) was used to determine the sedation level of each patient. The minimum and maximum values for BIS were between 0 and 100. Lower scores mean a deep sedation level.

  The time interval immediately after the surgery starts and immediately after the surgery ends.

• Pain intensity

  The Verbal Rating Scale was used to determine severity of the pain in the perioperative period. VRS is a 5-point scale including expressions defining the level of pain intensity (no pain, mild pain, moderate pain, intense pain and maximum pain). Higher scores mean intense pain.

  The time interval between the start of the surgery and the end of the surgery.

Secondary Outcomes (3)

• Side effects

  The time interval between the start and the end of the surgery.

• Surgeon's satisfaction

  Immediately after the surgeon finishes the operation.

• Pain intensity

  Immediately after the surgical procedure is completed and the patient is transferred to the postoperative care unit and before the patient is transferred to the outpatient service.

Study Arms (2)

Dexmedetomidine infusion

ACTIVE COMPARATOR

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.

Drug: Dexmedetomidine infusion

Remifentanil infusion

ACTIVE COMPARATOR

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.

Drug: Remifentanil infusion

Interventions

Dexmedetomidine infusion 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.

Also known as: Cataract surgery

Dexmedetomidine infusion

Remifentanil infusion 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.

Also known as: Cataract surgery

Remifentanil infusion

Eligibility Criteria

• Age: 65 Years - 80 Years
• Gender Eligibility Details: Patients between the ages of 65-80 were enrolled in the study.
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Selcuk University: lead
• Hacettepe University: collaborator

Study Sites (1)

Hacettepe University

Ankara, Sıhhiye, 06100, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 31535721 BACKGROUND

MeSH Terms

Conditions

Personal Satisfaction; Cataract

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Behavior; Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Nalan Celebi, Professor

  Hacettepe University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The surgeon who performed the surgery, the participants included in the study, and the technician who collected the study data were unaware of the study groups and the type of drugs used for sedation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 7, 2021
• First Posted: June 23, 2021
• Study Start: March 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: July 1, 2010
• Last Updated: June 23, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)