Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202210764449003 Date of Approval: 04/10/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Efficacy of a premedication with melatonin during cataract surgery under peribulbar block: a prospective randomized double-blinded study
Official scientific title Efficacy of a premedication with melatonin during cataract surgery under peribulbar block: a prospective randomized double-blinded study
Brief summary describing the background and objectives of the trial Cataract surgery is ubiquitous often performed on an outpatient basis under sedation and locoregional anesthesia. The objective of the study is to evaluate a premedication with melatonin on the quality of intraoperative sedation-analgesia during cataract surgery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Eye Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 15/08/2022
Actual trial start date
Anticipated date of last follow up 30/09/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group M Melatonin 10 mg once participants receive 10 mg of melatonin by sublingual route sixty minutes before the surgery 30
Control Group Group P Sucralose 05 tablets once participants receive 05 tablets of sucralose sixty minutes before surgery 30 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
oral and written informed consent of the patients an age over 50 years old an ASA class I, II, III a cataract of senile origin a cataract complicating an ophthalmological pathology such as uveitis or pigmentary retinopathy a cataract complicating an extra-orbital pathology such as diabetes, chronic inflammatory diseases and hypoparathyroidism a post-traumatic cataract a cataract of iatrogenic origin following long-term corticosteroid therapy or orbital radiation therapy a psychiatric history a history of long-term use of sedatives, anxiolytics or analgesics a history of complications from ophthalmic surgery sleep disorders cognitive or sensory disorders a congenital cataract (embryopathies or hereditary) a cataract secondary to genetic diseases such as Trisomy 21 or Steinert’s dystrophy a secondary cataract on implant following a posterior capsular opacification a strong myopia staphyloma a glaucoma in the controlateral eye a contraindication of the use of melatonin a contraindication to loco-regional anesthesia any indications to convert to general anesthesia such as failure of loco-regional anesthesia technique failure to comply with the 60-minute premedication period a surgical procedure that has exceeded the half-elimination time of melatonin (120 minutes) an intra operative anesthetic complications an intra operative surgical complications such as an expulsive hemorrhage of the eyeball, rupture of the capsule with vitreous exit, capsular or zonular rupture, or a non compliant implant 80 and over: 80+ Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 50 Year(s) 100 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 22/07/2022 CEFMS
Ethics Committee Address
Street address City Postal code Country
Rue Mohamed Karoui 4002 Sousse Tunisie Sousse 4002 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome a 50 percent reduction in the average total dose of intraoperative midazolam and alfentanyl consumption with melatonin premedication at the end of the surgery
Secondary Outcome intra operative sedation at the time of induction of the peribulbar block, at 05 minutes of the beginning of the surgery, at 15 minutes of the beginning of the surgery,at the end of the surgery
Secondary Outcome intraoperative analgesia at the induction of peribulbar block, at 05 minutes of the beginning of the surgery, at 15 minutes of the the beginning of the surgery,and at the end of the surgery
Secondary Outcome Perioperative anxiety during the pre-anesthestic visit and in the operating room just before induction of sedation
Secondary Outcome Intraocular pressure pre-operatively during ophtalmological consultation, in the operating room before the induction of the peribulbar block, and post-operatively at H24
Secondary Outcome Patients satisfaction at the end of the surgery in the recovery room
Secondary Outcome Surgeons satisfaction at the end of the surgery
Secondary Outcome total dose of bolus of nicardipine at the end of the surgery
Secondary Outcome recovery of psychomotor function at the end of the surgery in the recovery room
Secondary Outcome advese effects of melatonin at the end of the surgery in the recovery room
Secondary Outcome heart rate during the pre-anesthetic visit, on admission to the operating room, at 01 minute of sedation induction, at 05 minutes of the beginning of the surgical act, at 15 minutes of the beginning of the surgi
Secondary Outcome respiratory rate during the pre-anesthetic visit, on admission to the operating room, at 01 minute of sedation induction, at 05 minutes of the beginning of the surgical act, at 15 minutes of the beginning of the surgi
Secondary Outcome Pulsed O2 saturation during the pre-anesthetic visit, on admission to the operating room, at 01 minute of sedation induction, at 05 minutes of the beginning of the surgical act, at 15 minutes of the beginning of the surgi
Secondary Outcome Systolic arterial blood pressure during the pre-anesthetic visit, on admission to the operating room, at 01 minute of sedation induction, at 05 minutes of the beginning of the surgical act, at 15 minutes of the beginning of the surgi
Secondary Outcome Diastolic arterial blood pressure during the pre-anesthetic visit, on admission to the operating room, at 01 minute of sedation induction, at 05 minutes of the beginning of the surgical act, at 15 minutes of the beginning of the surgi
Secondary Outcome Mean arterial blood pressure during the pre-anesthetic visit, on admission to the operating room, at 01 minute of sedation induction, at 05 minutes of the beginning of the surgical act, at 15 minutes of the beginning of the surgi
Secondary Outcome Occurence of an oculo-cardiac reflex at the induction of peribulbar block, at 05 minutes of the beginning of the surgery, at 15 minutes of the the beginning of the surgery,and at the end of the surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Department of anesthesia and surgical resuscitation of the Farhat HACHED University Teaching Hospital Avenue Ibn ElJazzar Sousse 4000 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Anesthesia and intensive care Department Avenue Ibn ElJAZZAR Sousse 4000 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Pr. Hosni KHOUADJA 1, Rue Ahmed KHEIREDDINE KHEZAMA-EST Sousse 4051 Tunisia Individual
COLLABORATORS
Name Street address City Postal code Country
Fadoua MIGHRI 28, Rue el Bostene Cite Olfa El mourouj 4 Ben AROUS 2074 Tunisia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hosni KHOUADJA hosny_kh@yahoo.fr +21698403162 1, Rue Ahmed KHEIREDDINE KHEZAMA-EST
City Postal code Country Position/Affiliation
Sousse 4051 Tunisia Anesthesia and intensive care department
Role Name Email Phone Street address
Public Enquiries Fadoua MIGHRI fadouamighri@gmail.com +21695635175 28, Rue elbostene cite olfa Elmourouj4
City Postal code Country Position/Affiliation
Ben AROUS 2074 Tunisia Anesthesia and intensive care department
Role Name Email Phone Street address
Scientific Enquiries Khaled BenJAZIA khaled.benjazia@rns.tn +21699623123 Rue Kalaa SGHIRA
City Postal code Country Position/Affiliation
Sousse 4021 Tunisia Anesthesia and intensive care department
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All data and results of this trial will be shared publicly on demand with whom it may concern by mailing the principal investigator and on the plateform of PACTR Informed Consent Form,Statistical Analysis Plan,Study Protocol results of the study will be available Fromm December 2022 to December 2024 open access, all data are permitted, by mail to the principal investigator, students, doctors, professors in medecine
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information