Strabismus Clinical Trial
Official title:
The Effect of Rocuronium as an Anesthetic Adjuvant in Peribulbar Anesthesia for Adult Strabismus Surgery: Randomized Controlled Double-blind Study
- 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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 2, 2024 |
Est. primary completion date | December 2, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 60 Years |
Eligibility | Inclusion Criteria: - Adult patients - Aged 21- 60 years - American Society of Anesthesiologists class (ASA) I to III - presented for elective strabismus surgery under peribulbar anesthesia. Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Egypt | Tanta University | Tanta | Algharbia |
Lead Sponsor | Collaborator |
---|---|
Tanta University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | The onset of sensory block | Time interval from peribulbar injection till loss of corneal sensation | Intraoperative (every 2 minutes after peribulbar injection) | |
Secondary | The duration of sensory block | time interval from the peribulbar injection till regaining corneal sensation, | Intraoperative (Every 30 minutes in the first 4 hours) |
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