AnxietyPhase 1/2NCT01200641
Evaluation of Anxiolysis and Pain Associated With Retrobulbar Eye Block for Cataract Surgery : Melatonin Versus Gabapentin
A Phase 1/2 study testing Melatonin and Gabapentin in people with Anxiety and Pain, run by Qazvin University Of Medical Sciences at 1 site in Iran.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 35 to 85 years
- What is being tested?
- Melatonin and Gabapentin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteIran
- Study dates
- Sep 2010to Jan 2011
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who were aged 25 years or older, American Society of Anesthesiologists (ASA) physical status I-III
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Iran1 site
Qazvin university of medical science
Qazvin, Qazvin Province, 34197/59811
About this study
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)
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.
- Being tested
- Melatonin, Gabapentin, placebo
- Keywords
- melatonin, gabapentin, anxiety, pain, retrobulbar block
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDrug
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).
GabapentinDrug
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).
placeboDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| melatonin | Active comparator | 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). Receives: Drug: Melatonin |
| gabapentin | Active comparator | 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). Receives: Drug: Gabapentin |
| placebo | Placebo comparator | 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). Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain will be assessed by verbal pain score (VPS) of 10 (0 = no pain and 10 = worst pain imaginable)
Measured: one minute after retrobulbar block placement
pain will be assessed by verbal pain score (VPS) of 10 (0 = no pain and 10 = worst pain imaginable)
Measured: 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)
pain will be assessed by verbal pain score (VPS) of 10 (0 = no pain and 10 = worst pain imaginable)
Measured: postoperatively before discharging the patient from the recovery room
anxiety will be assessed by verbal anxiety score (VAS) of 10 (0 = completely calm and 10 = the worst possible anxiety)
Measured: 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)
anxiety will be assessed by verbal anxiety score (VAS) of 10 (0 = completely calm and 10 = the worst possible anxiety)
Measured: one minute after retrobulbar block placement
anxiety will be assessed by verbal anxiety score (VAS) of 10 (0 = completely calm and 10 = the worst possible anxiety)
Measured: postoperatively before discharging the patient from the recovery room
Secondary outcomes (12)
mean arterial blood pressure will be assessed by noninvasive automatic blood pressure measurement
Measured: before premedication
mean arterial blood pressure will be assessed by noninvasive automatic blood pressure measurement
Measured: ninety minutes after premedication, on arrival in the operating room
mean arterial blood pressure will be assessed by noninvasive automatic blood pressure measurement
Measured: one minute after retrobulbar block placement
mean arterial blood pressure will be assessed by noninvasive automatic blood pressure measurement
Measured: during the operation period(five minutes after beginning of surgery
mean arterial blood pressure will be assessed by noninvasive automatic blood pressure measurement
Measured: postoperatively before discharge the patient from the recovery room
heart rate will be assessed by echocardiogram monitoring
Measured: before premedication
heart rate will be assessed by echocardiogram monitoring
Measured: ninety minutes after premedication, on arrival in the operating room
heart rate will be assessed by echocardiogram monitoring
Measured: one minute after retrobulbar block placement
heart rate will be assessed by echocardiogram monitoring
Measured: during the operation period(five minutes after beginning of surgery
heart rate will be assessed by echocardiogram monitoring
Measured: postoperatively before discharge the patient from the recovery room
satisfaction of surgeon according to three degree scale as very bad, moderate, good will be assessed
Measured: one minute after retrobulbar block placement
satisfaction of surgeon according to three degree scale as very bad, moderate, good will be assessed
Measured: at the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionDec 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qazvin University Of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, marzieh beigom khezri, Qazvin University Of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01200641
- Sponsor's protocol ID
- ACTRN12610000727044
- Status last verified
- Oct 2012
- First submitted
- 10 Sep 2010
- Last updated
- 11 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01200641
- Acronym / sponsor ID
- ACTRN12610000727044
- Keywords
- melatonin, gabapentin, anxiety, pain, retrobulbar block
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Qazvin University Of Medical SciencesUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 13 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| melatonin | Active comparator | Drug: Melatoninninety 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). |
| gabapentin | Active comparator | Drug: Gabapentinninety 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 | Placebo comparator | Drug: placeboninety 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). |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients who were aged 25 years or older, American Society of Anesthesiologists (ASA) physical status I-III
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Melatoninninety 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 |
| Gabapentinninety 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 |
| placeboninety 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 |
Primary outcome
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
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)
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
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)
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
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
12 secondary outcomes
mean arterial blood pressure will be assessed by noninvasive automatic blood pressure measurement
Time frame: before premedication
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
mean arterial blood pressure will be assessed by noninvasive automatic blood pressure measurement
Time frame: one minute after retrobulbar block placement
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
mean arterial blood pressure will be assessed by noninvasive automatic blood pressure measurement
Time frame: postoperatively before discharge the patient from the recovery room
heart rate will be assessed by echocardiogram monitoring
Time frame: before premedication
heart rate will be assessed by echocardiogram monitoring
Time frame: ninety minutes after premedication, on arrival in the operating room
heart rate will be assessed by echocardiogram monitoring
Time frame: one minute after retrobulbar block placement
heart rate will be assessed by echocardiogram monitoring
Time frame: during the operation period(five minutes after beginning of surgery
heart rate will be assessed by echocardiogram monitoring
Time frame: postoperatively before discharge the patient from the recovery room
satisfaction of surgeon according to three degree scale as very bad, moderate, good will be assessed
Time frame: one minute after retrobulbar block placement
satisfaction of surgeon according to three degree scale as very bad, moderate, good will be assessed
Time frame: at the end of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Melatonin and Gabapentin in people with Anxiety and Pain, run by Qazvin University Of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2012.