Suez canal university
Ismailia, Egypt
NCT Number: NCT06784843
50 patients of both sexes, ages 18 to 75, who were scheduled for cataract surgery and had physical status I or II according to the American Society of Anesthesiologists were included in this study.
After induction of general anesthesia, all patients received peribulbar block. In group A (midazolam group), 25 patients received midazolam. In group B (dexmedetomidine group), 25 patients received dexmedetomidine.
Looking for future studies?
Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Ismailia, Egypt
Background: Peribulbar blocks are commonly used for cataract surgery, providing effective anesthesia with reduced recovery time. The addition of sedative agents, such as dexmedetomidine or midazolam, may enhance the anesthetic effect and patient comfort while maintaining hemodynamic stability. However, the optimal sedative agent for use in this context remains uncertain.
Objective: This study aimed to compare the efficacy and safety of dexmedetomidine and midazolam as adjuvants to local anesthetic in peribulbar blocks for cataract surgery.
Methods: A randomized, double-blind clinical trial included 50 patients aged 18-75 years with the American Society of Anesthesiologists physical status I-II who were scheduled for cataract surgery under peribulbar block. Participants were randomly allocated to two groups: Group A received midazolam (1 mg), and Group B received dexmedetomidine (50 µg), combined with a standard mixture of local anesthetics. The primary outcomes included the onset and duration of motor and sensory block and lid akinesia. Secondary outcomes assessed the quality of motor and sensory block, lid akinesia using the Ocular Anesthesia Scoring System, sedation levels using the Ramsay Sedation Score, the occurrence of local or systemic complications, and satisfaction levels reported by both patients and surgeons.
Keywords: dexmedetomidine; midazolam; peribulbar block; cataract surgery.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Dexmedetomidine as an adjuvant to a local anesthetic mixture (bupivacaine, lidocaine, and hyaluronidase) for peribulbar block during cataract surgery
Other names: DEX
Midazolam as an adjuvant to a local anesthetic mixture (bupivacaine, lidocaine, and hyaluronidase) for peribulbar block during cataract surgery
Other names: MID
Time frame: Intraoperative from the moment of local anesthesia injection until the moment of complete and full globe akinesia up to 1 hour
The period of time that passed after the local anesthetic mixture was injected before the eye globe was completely immobile
Time frame: Intraoperative from the moment of local anesthesia injection until the moment of complete insensitivity and absent reflexes of the eye up to 1 hour
the period of time following the local anesthetic mixture injection that resulted in total insensitivity and absent eye reflexes
Time frame: Periperative from the moment of complete and full globe akinesia until the moment of return back of eye movement up to 1 hour
The time it takes for the entire eye globe to return to free motion after experiencing akinesia
Time frame: Periperative from the moment of complete areflexia until the moment of return back of sensation and reflexes up to 1 hour
The amount of time before the entire eye globe regains sensation after experiencing insensitivity and areflexia andreflexes
Suez Canal University
Other
Dexmedetomidine Versus Midazolam as an Adjuvant to Local Anesthetic Mixture (Bupivacaine, Lidocaine, and Hyaluronidase) for Peribulbar Block During Cataract Surgery: A Randomized Controlled Trial
Acronym: peribulbar
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07735000
Age Related Cataract, Cataract
Peshawar, KPK, Pakistan
View Trial DetailsNCT07605260
Cataract, Eye Diseases
Islamabad, Punjab Province, Pakistan
View Trial DetailsNCT06428955
Cataract, Eye Diseases
Indianapolis, Indiana, United States
View Trial DetailsNCT06111222
Cataract, Eye Diseases
Heidelberg, Germany
View Trial Details