Efficacy of Dexmedetomidine for Postoperative Analgesia in Infantile Cataract Surgery

• ClinicalTrials.gov Identifier: NCT02495220
• Recruitment Status: Unknown
• First Posted: July 13, 2015
• Last Update Posted: January 27, 2017
• Sponsor: Assiut University
• Information provided by (Responsible Party): jehan ahmed sayed, Assiut University

Study Description

Brief Summary:

The purpose of the present study was to evaluate the efficacy and safety of subtenon block (SB)anesthesia with dexmedetomidine in combination with bupivacaine versus intravenous dexmedetomidine for postoperative analgesia and emesis control in infants undergoing cataract surgery.

Condition or disease	Intervention/treatment	Phase
Postoperative Pain; Postoperative Vomiting	Drug: SB dexmedetomidine bupivacaine block; Drug: intravenous dexmedetomidine	Phase 2; Phase 3

Detailed Description:

In this prospective, randomized, controlled, double blind trial eighty ASA physical status grade I and II infants (1-12month) undergoing elective cataract surgery in one eye under general anesthesia were studied. Infants were randomly allocated to one of the two groups: subtenon block Group (SB) with dexmedetomidine (n =40) or intravenous dexmedetomidine Group (IV) (n =40). After securing the airway, infants in Group (SB) received SB block with 0.05 mL/kg of 0.5%bupivacaine and 0.5µ/kg dexmedetomidine mixture, whereas infants in Group (IV) received 1µ/kg IV dexmedetomidine after induction of anesthesia. Surgery started after 5 min of study drug administration. Postoperative assessment for number of infants requiring rescue analgesia and rescue antiemetics was the primary outcome. CRIES pain scale score , vomiting scale score during4-h study period, incidence of oculocardiac reflex and any surgical difficulty were the Secondary outcomes.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Subtenon Versus Intravenous Dexmedetomidine for Postoperative Analgesia and Vomiting Control in Infantile Cataract Surgery
• Study Start Date: July 2015
• Estimated Primary Completion Date: November 2017
• Estimated Study Completion Date: November 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: subtenon block Group (SB); received SB block with 0.05 mL/kg of 0.5%bupivacaine and 0.5µ/kg dexmedetomidine mixture	Drug: SB dexmedetomidine bupivacaine block; SB block with 0.05 mL/kg of 0.5%bupivacaine and 0.5µ/kg dexmedetomidine mixture
Experimental: intravenous dexmedetomidine Group(IV); received 1µ/kg IV dexmedetomidine after induction of anesthesia	Drug: intravenous dexmedetomidine; received 1µ/kg IV dexmedetomidine

Outcome Measures

Primary Outcome Measures :

1. Postoperative assessment for number of infants requiring rescue analgesia and rescue antiemetics [ Time Frame: 4 hours postoperatively ]
   by analysis for number of infants withCRIES pain scale score >3
2. postoperative CRIES pain scale score [ Time Frame: 4 hours postoperatively ]
   (0-2 for each parameter)

Secondary Outcome Measures :

1. vomiting scale score [ Time Frame: 4 hours postoperative ]
   a numeric rank score, where 0= no vomiting 1=vomited once and 2=vomited twice or more
2. Number of oculocardiac reflex(OCR)events(acute reduction in heart rate of >20%). [ Time Frame: intraoperative period ]
   by analysis

Eligibility Criteria

• Ages Eligible for Study: 1 Month to 12 Months (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. ASA physical status grade I and II infants (1-12month).
2. undergoing elective cataract surgery in one eye under general anesthesia.

Exclusion Criteria:

1. infection of the orbit,
2. increased intraocular pressure(IOP),
3. history of allergy to local anesthetics,
4. history of previous eye surgery,
5. cardiovascular or clotting disorders,
6. full stomach,inner ear disorders or other conditions predisposing to vomiting
7. airway abnormalities
8. compromised sclera.

Contacts and Locations

Contacts

Contact: jehan A sayed, MD; +2 01006253939; jehan.alloul@yahoo.com

Locations

Egypt

Assiut Univeristy Hospital; Recruiting

Assiut, Egypt, 71515

Contact: jehan A Sayed, MD +2 01006253939 jehan.alloul@yahoo.com

Contact: MD

Sub-Investigator: Mohamed Amir F Riad, MD

Principal Investigator: jehan A Sayed, MD

Sponsors and Collaborators

Assiut University

More Information

• Responsible Party: jehan ahmed sayed, assistant professor in anesthesia and intensive care department,faculty of medicine assiut university, Assiut University
• ClinicalTrials.gov Identifier: NCT02495220
• Other Study ID Numbers: IRB00008711068
• First Posted: July 13, 2015
• Last Update Posted: January 27, 2017
• Last Verified: January 2017

Keywords provided by jehan ahmed sayed, Assiut University:

dexmedetomidine; subtenon anesthesia; postoperative pain; pov

Additional relevant MeSH terms:

Cataract; Pain, Postoperative; Vomiting; Postoperative Nausea and Vomiting; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Lens Diseases; Eye Diseases; Signs and Symptoms, Digestive; Nausea; Dexmedetomidine; Bupivacaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents; Hypnotics and Sedatives; Analgesics, Non-Narcotic; Analgesics; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action