Dexmedetomidine in Topical Versus Peribulbar Anesthesia for Cataract Surgery

Sponsor
Kafrelsheikh University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05692167
Collaborator
(none)
94
1
2

Study Details

Study Description

Brief Summary

The aim of this study is to compare efficacy of dexmedetomidine as an additive to topical versus peribulbar anesthesia for cataract surgery

Condition or Disease Intervention/Treatment Phase
  • Drug: Topical dexmedetomidine
  • Drug: Reginal dexmedetomidine
Phase 2

Detailed Description

Ocular surgery may be performed under topical, regional, or general anesthesia. The first recorded use of regional anesthesia for surgery was the instillation of cocaine into the conjunctival sac in 1884 by an Austrian ophthalmologist.

Davis and Mandel in 1986 described the peribulbar block, peribulbar block has delayed onset and need a higher volume of local anesthetic (LA) than a retrobulbar block. But the peribulbar block is away from intra-conal space and so produce fewer complication.

Dexmedetomidine is used as adjuvant to LA drugs in peripheral nerve block, brachial plexus block and intrathecal anesthesia with satisfactory results. A more recent study using dexmedetomidine (50 μg) with the peribulbar block before cataract surgery demonstrated an IOP decrease similar to IV dexmedetomidine administration and greater than a peribulbar block without dexmedetomidine.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
94 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Dexmedetomidine as an Additive to Topical Versus Peribulbar Anesthesia for Cataract Surgery
Anticipated Study Start Date :
Jul 15, 2023
Anticipated Primary Completion Date :
Jul 15, 2023
Anticipated Study Completion Date :
Jul 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Topical dexmedetomidine group

Patients will receive mixture of one milliliter of dexmedetomidine-HCl and local anesthetic

Drug: Topical dexmedetomidine
Patients will receive mixture of one milliliter of dexmedetomidine-HCl and local anesthetic

Active Comparator: Reginal dexmedetomidine group

Patients will receive mixture of bupivacaine 0.5% (4.5 ml) + lidocaine 2% (4.5 ml) + dexmedetomidine 50 μg (1 ml) in peribulbar block

Drug: Reginal dexmedetomidine
Patients will receive mixture of bupivacaine 0.5% (4.5 ml) + lidocaine 2% (4.5 ml) + dexmedetomidine 50 μg (1 ml) in peribulbar block

Outcome Measures

Primary Outcome Measures

  1. Inadvertent eye movement [2 hours postoperatively]

    Asses intra-ocular pressure (IOP) before injection of baseline and after a complete akinesia of the globe before surgical incision.

Secondary Outcome Measures

  1. Anesthesia-related complications [2 hours postoperatively]

    The patients will be asked whether the cataract surgery was more or less painful than having the needle used for intravenous infusions inserted into the back of the hand.

  2. Sedation level [2 hours postoperatively]

    Numeric Rating Scale will be applied to grade the pain where 0 = no pain and 10 = extreme pain.

  3. pain during and after the surgery [2 hours postoperatively]

    Immediately after surgery, patients will be asked to grade the pain felt during the operation, including the pain felt after delivery of topical or peribulbar anaesthesia.

  4. Need for additional anesthesia during surgery and surgeon [During surgery]

    The dose of additional needed anesthesia (fentanyl 0.5 µg/kg) during surgery will be recorded

  5. Intraoperative difficulties [2 hours postoperatively]

    The surgeon will also be requested to grade any difficulties encountered during surgery immediately after the operation, using a 4-point scale, where 1 = no difficulty and 4 = extremely difficult

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • American Society of Anesthesiologists (ASA) physical status classification I or II who scheduled for eye surgery
Exclusion Criteria:
  • Patients who are younger than 18 years

  • The usual contraindications for regional anesthesia such as patients refusing LA

  • Clotting abnormalities

  • Impaired mental status

  • Allergy to any of the study medications

  • patients had the severe cardiac disease

  • chronic obstructive lung disease and a history of sleep apnea

  • contraindications to the use of dexmedetomidine

  • history or significant cardiovascular disease risk factors

  • significant coronary artery disease or any known genetic predisposition

  • history of any kind of drug allergy

  • drug abuse

  • psychological or other emotional problems

  • special diet or lifestyle

  • clinically significant abnormal findings in physical examination

  • electrocardiographic (ECG) or laboratory screening

  • known systemic disease requiring the use of anticoagulants.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mohammed Fouad Mohamed Algyar Kafrelsheikh Egypt 33516

Sponsors and Collaborators

  • Kafrelsheikh University

Investigators

  • Principal Investigator: Mohammed F Algyar, MD, Lecturer of Anaesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Kafrelsheikh University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mohamed Fouad Algyar, Lecturer of Anaesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Kafrelsheikh University, Kafrelsheikh University
ClinicalTrials.gov Identifier:
NCT05692167
Other Study ID Numbers:
  • MKSU 50-11-3
First Posted:
Jan 20, 2023
Last Update Posted:
Jan 20, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 20, 2023