Peribulbar Rocuronium in Adult Strabismus Surgery

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; -

1. Patient age, weight, height, gestational age, and gravidity.
2. The duration of globe akinesia (primary outcome).
3. The onset of lid and globe akinesia and the duration of lid akinesia
4. The onset and duration of sensory block
5. Time required to start the surgery
6. Akinesia score
7. 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.
8. Any detected complication as nausea and vomiting, pain on injection, or increased intraocular tension.

Conditions

• Strabismus
• Regional Anesthesia Morbidity
• Rocuronium

Interventions

DRUG

Normal saline

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

Rocuronium

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.

Sponsors & Collaborators

• Tanta University

  lead OTHER

Principal Investigators

• Sameh Abdelkhalik, M.D · Tanta University

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-04-03

Primary Completion

2025-02-09

Completion

2025-02-09

Countries

• Egypt

Study Locations