The Effect of Rocuronium as an Anesthetic Adjuvant in Peribulbar Anesthesia for Adult Strabismus Surgery: Randomized Controlled Double-blind Study

Status: Completed
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 60
Healthy Volunteers: f
View:

• Adult patients

• Aged 21- 60 years

• American Society of Anesthesiologists class (ASA) I to III

• presented for elective strabismus surgery under peribulbar anesthesia.

Locations
Other Locations
Egypt
Tanta University
Tanta
Time Frame
Start Date: 2021-04-03
Completion Date: 2025-02-09
Participants
Target number of participants: 52
Treatments
Placebo_comparator: Group C (Control group)
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.
Experimental: Group R (rocuronium group)
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.
Related Therapeutic Areas
Sponsors
Leads: Tanta University

This content was sourced from clinicaltrials.gov