Clinical trial

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

Name
34506/2/21
Description
* 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.
Trial arms
Trial start
2021-04-03
Estimated PCD
2024-12-02
Trial end
2024-12-02
Status
Recruiting
Treatment
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.
Arms:
Group C (Control group)
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.
Arms:
Group R (rocuronium group)
Size
50
Primary endpoint
The duration of globe akinesia
up to first 2 hours intraoperative
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': '* The patients will be blinded to their groups.\n* 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.\n* The anesthetist who will perform the peribulbar block will be blinded to the local anesthetic mixtures he will inject.\n* 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', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}
Updated at
2024-04-16

1 organization

1 product

1 drug

3 indications

Organization
Tanta University
Indication
Strabismus
Indication
Rocuronium
Product
Rocuronium