Evaluation of Anxiolysis and Pain Associated With Retrobulbar Eye Block for Cataract Surgery : Melatonin Versus Gabapentin
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Purpose
Principle goals of sedation for eye surgery are to provide patient comfort and to allow the patient to stay calm during both retrobulbar injection and surgery. Insufficient sedation may not prevent the patient from moving during retrobulbar injection, whereas very deep sedation may result in respiratory complications during surgery .The investigators compared the effect of melatonin and gabapentin on the hemodynamic parameters, sedation ,anxiety, and pain and satisfaction profile in cataract surgery. After approval by the Hospital Evaluation Committee of Scientific Studies for ethical purpose and written informed consent, ninety patients scheduled for cataract surgery by phacoemulsification were randomly allocated to three study groups to receive melatonin 6 mg (Group M, n = 30) , gabapentin 600mg(GroupG, n = 30)or placebo(GroupP, n=30) 90 minutes before retrobulbar injection. . Hemodynamic parameters ,anxiety, sedation score , and pain during block and surgery, satisfaction of surgeon were assessed. . At the preoperative visit verbal pain score (VPS) of 10 (0 = no pain and 10 = worst pain imaginable) and verbal anxiety score (VAS) ranging from 0 to 10 (0= completely calm, 10 = the worst possible anxiety) were explained to patients. Then a 20 gauge cannula was inserted into one of the two hands. Patients were monitored with electrocardiogram, noninvasive measurement of blood pressure, and pulse oximetry (SPO2). Retrobulbar nerve block was performed by the same ophthalmic surgeon who was unaware of group allocation with 1.5 ml of solution that prepared by nurse( lidocaine 2%and 0.5 ml bupivacaine) via the percutaneous route with a 25 G, 38 mm Atkinson needle (John Weiss & Son Limited, Milton Keynes,England), at inferotemporal site. No patient received an additional facial nerve block. The investigators assessed the pain immediately after block and surgery. Anxiety score and pain score was recorded in each patient before premedication (T1), ninety minutes after premedication, on arrival in the operating room (T2), one minute after retrobulbar block placement (T3)during the operation period) (T4) and postoperatively before discharging the patient from the recovery room (T5) .At the end of surgery, the patients were asked about average level of their anxiety and pain during the operation period according to the VAS and VPS explained to them before premedication.`. The surgeon was also asked to verbally rate their level of satisfaction according to three degree scale as "very bad, , moderate, good after the operation. The sedation level of patients during performance of block was assessed as Sedation scores were obtained on a 3 point scale with 0 =movements of the head, arms and trunk ,1 =slightly movement of arms,2=slightly change in face,3=complete calm. If sedation was inadequate, fentanyl could be given 0.5microgram/kg as needed.
| Condition | Intervention | Phase |
|---|---|---|
|
Anxiety Pain |
Drug: Melatonin Drug: Gabapentin Drug: placebo |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Evaluation of Anxiolysis and Pain Associated With Retrobulbar Eye Block for Cataract Surgery : Melatonin Versus Gabapentin ( A Randomized, Double-blind, Placebo-controlled Study) |
- pain will be assessed by verbal pain score (VPS) of 10 (0 = no pain and 10 = worst pain imaginable) [ Time Frame: one minute after retrobulbar block placement ] [ Designated as safety issue: Yes ]
- pain will be assessed by verbal pain score (VPS) of 10 (0 = no pain and 10 = worst pain imaginable) [ Time Frame: At the end of surgery the patients were asked about average level of their pain during the operation period according to the VPS explained to them before premedication) ] [ Designated as safety issue: Yes ]
- pain will be assessed by verbal pain score (VPS) of 10 (0 = no pain and 10 = worst pain imaginable) [ Time Frame: postoperatively before discharging the patient from the recovery room ] [ Designated as safety issue: Yes ]
- anxiety will be assessed by verbal anxiety score (VAS) of 10 (0 = completely calm and 10 = the worst possible anxiety) [ Time Frame: At the end of surgery the patients were asked about average level of their pain during the operation period according to the VPS explained to them before premedication) ] [ Designated as safety issue: Yes ]
- anxiety will be assessed by verbal anxiety score (VAS) of 10 (0 = completely calm and 10 = the worst possible anxiety) [ Time Frame: one minute after retrobulbar block placement ] [ Designated as safety issue: Yes ]
- anxiety will be assessed by verbal anxiety score (VAS) of 10 (0 = completely calm and 10 = the worst possible anxiety) [ Time Frame: postoperatively before discharging the patient from the recovery room ] [ Designated as safety issue: Yes ]
- mean arterial blood pressure will be assessed by noninvasive automatic blood pressure measurement [ Time Frame: before premedication ] [ Designated as safety issue: Yes ]
- mean arterial blood pressure will be assessed by noninvasive automatic blood pressure measurement [ Time Frame: ninety minutes after premedication, on arrival in the operating room ] [ Designated as safety issue: Yes ]
- mean arterial blood pressure will be assessed by noninvasive automatic blood pressure measurement [ Time Frame: one minute after retrobulbar block placement ] [ Designated as safety issue: Yes ]
- mean arterial blood pressure will be assessed by noninvasive automatic blood pressure measurement [ Time Frame: during the operation period(five minutes after beginning of surgery ] [ Designated as safety issue: Yes ]
- mean arterial blood pressure will be assessed by noninvasive automatic blood pressure measurement [ Time Frame: postoperatively before discharge the patient from the recovery room ] [ Designated as safety issue: Yes ]
- heart rate will be assessed by echocardiogram monitoring [ Time Frame: before premedication ] [ Designated as safety issue: Yes ]
- heart rate will be assessed by echocardiogram monitoring [ Time Frame: ninety minutes after premedication, on arrival in the operating room ] [ Designated as safety issue: Yes ]
- heart rate will be assessed by echocardiogram monitoring [ Time Frame: one minute after retrobulbar block placement ] [ Designated as safety issue: Yes ]
- heart rate will be assessed by echocardiogram monitoring [ Time Frame: during the operation period(five minutes after beginning of surgery ] [ Designated as safety issue: Yes ]
- heart rate will be assessed by echocardiogram monitoring [ Time Frame: postoperatively before discharge the patient from the recovery room ] [ Designated as safety issue: Yes ]
- satisfaction of surgeon according to three degree scale as very bad, moderate, good will be assessed [ Time Frame: one minute after retrobulbar block placement ] [ Designated as safety issue: Yes ]
- satisfaction of surgeon according to three degree scale as very bad, moderate, good will be assessed [ Time Frame: at the end of surgery ] [ Designated as safety issue: Yes ]
| Enrollment: | 90 |
| Study Start Date: | September 2010 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: melatonin
ninety patients scheduled for cataract surgery by phacoemulsification were randomly allocated to three study groups to receive melatonin 6 mg (Group M, n = 30) , gabapentin 600mg(GroupG, n = 30)or placebo(GroupP, n=30) orally 90 minutes before retrobulbar injection( for all of three groups). |
Drug: Melatonin
ninety patients scheduled for cataract surgery by phacoemulsification were randomly allocated to three study groups to receive melatonin 6 mg (Group M, n = 30) , gabapentin 600mg(GroupG, n = 30)or placebo(GroupP, n=30) orally 90 minutes before retrobulbar injection( for all of three groups). |
|
Active Comparator: gabapentin
ninety patients scheduled for cataract surgery by phacoemulsification were randomly allocated to three study groups to receive melatonin 6 mg (Group M, n = 30) , gabapentin 600mg(GroupG, n = 30)or placebo(GroupP, n=30) orally 90 minutes before retrobulbar injection( for all of three groups). |
Drug: Gabapentin
ninety patients scheduled for cataract surgery by phacoemulsification were randomly allocated to three study groups to receive melatonin 6 mg (Group M, n = 30) , gabapentin 600mg(GroupG, n = 30)or placebo(GroupP, n=30) orally 90 minutes before retrobulbar injection( for all of three groups). |
|
Placebo Comparator: placebo
ninety patients scheduled for cataract surgery by phacoemulsification were randomly allocated to three study groups to receive melatonin 6 mg (Group M, n = 30) , gabapentin 600mg(GroupG, n = 30)or placebo(GroupP, n=30) orally 90 minutes before retrobulbar injection( for all of three groups). |
Drug: placebo
ninety patients scheduled for cataract surgery by phacoemulsification were randomly allocated to three study groups to receive melatonin 6 mg (Group M, n = 30) , gabapentin 600mg(GroupG, n = 30)or placebo(GroupP, n=30) orally 90 minutes before retrobulbar injection( for all of three groups). |
Eligibility| Ages Eligible for Study: | 35 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- patients who were aged 25 years or older, American Society of Anesthesiologists (ASA) physical status I-III
Exclusion Criteria:
- Patients with ASA status IV
- history of hepatic or renal disease, confusion, dementia
- communication difficulty resulting from deafness or language barrier
- chronic use of narcotics, barbiturates or psychotropic medications
- history of allergy or contraindications to any of the study drugs
- visual impairment of the non operative eye
- weight < 40 kg or > 100 kg
Contacts and Locations
More Information
No publications provided
| Responsible Party: | marzieh beigom khezri, Qazvin University Of Medical Sciences |
| ClinicalTrials.gov Identifier: | NCT01200641 History of Changes |
| Other Study ID Numbers: | ACTRN12610000727044 |
| Study First Received: | September 10, 2010 |
| Last Updated: | October 10, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Qazvin University Of Medical Sciences:
|
melatonin gabapentin anxiety pain retrobulbar block |
Additional relevant MeSH terms:
|
Anxiety Disorders Cataract Mental Disorders Lens Diseases Eye Diseases Melatonin Gabapentin Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents |
Analgesics Sensory System Agents Peripheral Nervous System Agents Anticonvulsants Antiparkinson Agents Anti-Dyskinesia Agents Calcium Channel Blockers Membrane Transport Modulators Cardiovascular Agents Anti-Anxiety Agents Tranquilizing Agents Psychotropic Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents |
ClinicalTrials.gov processed this record on June 18, 2013