Comparative Study Between Using Combined Propofol Sedation With subTenon's Infusion as Local Anaesthsia to the Eye Versus General Anesthesia for Strabismus Surgery in Adults (squint anaesth)

March 25, 2026 updated by: Waleed Adel Ahmed, Sohag University

Comparative Study Between Combined Propofol Sedation With subTenon's Infusion Versus General Anesthesia for Strabismus Surgery in Adults

in this study investigators compare two type of anesthetic technique for squint surgery in adult patient first is general anesthesia versus local anesthesia using subtenon injection of local anesthetic. comparing patient and surgeon satisfaction in each group

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • horizontal or cyclovertical strabismus

Exclusion Criteria:

  • previous EOM surgery, retinal detachment, or filter operation. Patients with ocular or neurological problems, mental retardation, deafness, or dementia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: study group : subtenon injection of local anesthetic with propofol sedation
Procedure: sedation with subtenon injection of local anesthetic
sedation was induced with fentanyl a loading dose of propofol, followed by continuous infusion of propofol, 3-6 mg/k/h to deep sedation. A nasal tube was inserted to prevent airway obstruction. SubTenon's anaesthesia included "standard" solution is a mixture of 2% plain lignocaine, 0.5% plain bupivacaine, and 150 iu hyaluronidase 0.5%.
Active Comparator: controle group : patient receive general anesthesia
Procedure: General Anesthesia (control group)
General anaesthesia consisted of premedication with midazolam, followed by fentanyl, cis atracrium, propofol, and tracheal intubation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
patient satisfaction in combined propofol/sub-Tenon's anaesthesia in unilateral or bilateral strabismus surgery according to scale from 1 to 10 a one not satisfied and 10 completely satisfied
Time Frame: 12 hour after the end of the operation
12 hour after the end of the operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 10, 2026

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

June 10, 2026

Study Registration Dates

First Submitted

February 25, 2026

First Submitted That Met QC Criteria

March 25, 2026

First Posted (Actual)

March 31, 2026

Study Record Updates

Last Update Posted (Actual)

March 31, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-med-25-9----3PD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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