Peribulbar Rocuronium in Adult Strabismus Surgery

NCT04821817 | Completed

• 1 other identifier: 34506/2/21
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

• This is a prospective randomized clinical study that will be carried on adult patients aged from 21-60 years and presented for strabismus surgery under peribulbar anesthesia.
• Patients will be excluded if they refused to participate or had a contraindication to peribulbar anesthesia.
• Patients will be randomly distributed into either control group in which peribulbar anesthesia will be performed by injection of 10 ml local anesthetic mixture composed of 4 ml of plain bupivacaine 0.5%, 4 ml of lidocaine 2% containing 50 IU, and 2 ml normal saline or rocuronium group which peribulbar anesthesia will be performed by injection of 10 ml local anesthetic mixture composed of 4 ml of plain bupivacaine 0.5%, 4 ml of lidocaine 2% containing 50 IU, and 0.06 mg/kg of rocuronium in 2 ml normal saline.
• Measurements will include; -
• Patient age, weight, height, gestational age, and gravidity.
• The duration of globe akinesia (primary outcome).
• The onset of lid and globe akinesia and the duration of lid akinesia
• The onset and duration of sensory block
• Time required to start the surgery
• Akinesia score
• The visual analog score (VAS) which is composed of 0-10 score will be used to assess the severity of postoperative pain (where 0=no pain and 10=severe pain), The VAS score will be evaluated 1 h, 2 h postoperative, then every 2 h till 12 h. Any patients with VAS score more than 4 received rescue analgesia in the form of 50 mg tramadol intravenous injection with the calculation of the time for the first call of postoperative analgesia.
• Any detected complication as nausea and vomiting, pain on injection, or increased intraocular tension.

Conditions

Strabismus; Regional Anesthesia Morbidity; Rocuronium

Keywords

Strabismus; peribulbar anesthesia; rocuronium; akinesia

Outcome Measures

Primary Outcomes (1)

• The duration of globe akinesia

  Time interval from reaching the highest lid and globe akinesia score till restoration of the full lid and globe movement

  up to first 2 hours intraoperative

Secondary Outcomes (2)

• The onset of sensory block

  Intraoperative (every 2 minutes after peribulbar injection)

• The duration of sensory block

  Intraoperative (Every 30 minutes in the first 4 hours)

Study Arms (2)

Group C (Control group)

PLACEBO COMPARATOR

Patients in this group will receive peribulbar anesthesia with 10 ml local anesthetic mixture composed of 4 ml of plain bupivacaine 0.5%, 4 ml of lidocaine 2% containing 50 IU, and 2 ml normal saline.

Drug: Normal saline

Group R (rocuronium group)

EXPERIMENTAL

Patients in this group will receive peribulbar anesthesia with 10 ml local anesthetic mixture composed of 4 ml of plain bupivacaine 0.5%, 4 ml of lidocaine 2% containing 50 IU, and 0.06 mg/kg of rocuronium in 2 ml normal saline.

Drug: Rocuronium

Interventions

Normal saline DRUG

peribulbar anesthesia with 10 ml local anesthetic mixture composed of 4 ml of plain bupivacaine 0.5%, 4 ml of lidocaine 2% containing 50 IU, and 2 ml normal saline.

Group C (Control group)

Rocuronium DRUG

peribulbar anesthesia with 10 ml local anesthetic mixture composed of 4 ml of plain bupivacaine 0.5%, 4 ml of lidocaine 2% containing 50 IU, and 0.06 mg/kg of rocuronium in 2 ml normal saline.

Group R (rocuronium group)

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adult patients
• Aged 21- 60 years
• American Society of Anesthesiologists class (ASA) I to III
• presented for elective strabismus surgery under peribulbar anesthesia.

You may not qualify if:

• Patient refusal to participate.
• uncooperative patient.
• Neurological disorders.
• Psychological disorders
• Suspected or diagnosed coagulopathy.
• Known allergy to the used medications.
• Ocular infection
• Co-existing glaucoma

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, Algharbia, 31511, Egypt

Location

MeSH Terms

Conditions

Strabismus

Interventions

Saline Solution; Rocuronium

Condition Hierarchy (Ancestors)

Ocular Motility Disorders; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Sameh Abdelkhalik, M.D

  Tanta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: * The patients will be blinded to their groups. * An anesthesia resident who will not participate in the study and have no subsequent rule in it will help in the preparation of local anesthetic mixtures under strict aseptic precautions. * The anesthetist who will perform the peribulbar block will be blinded to the local anesthetic mixtures he will inject. * An assistant nurse who will be blinded to the study groups and will have no subsequent rule in it will help in a collection of the data of measurements
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: March 30, 2021
• Study Start: April 3, 2021
• Primary Completion: February 9, 2025
• Study Completion: February 9, 2025
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 6 months after approval of the publication of the trial.
• Access Criteria: Contact the principle investigator

Locations

EG (1)