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.: PACTR202101657899436 Date of Approval: 15/01/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Caffeine and spinal anestheis related hypotension
Official scientific title Impact of Oral Caffeine Premedication on Maternal and Fetal OUtcomes in Elective Cesarean Delivery Under Spinal Anesthesia: A Randomized Clinical Trial
Brief summary describing the background and objectives of the trial As being a safe technique widely used and tested in the gynecological field, spinal anesthesia is considered the first choice in cesarean delivery all over the world. It allows a quick valid sensor and motor blocks yielding an effective postoperative analgesia. However, hypotension is the most common and serious complication of spinal anesthesia in caesarean delivery. The most common definitions of hypotension used in the literature were either (SAP) <90 mmHg or < 80% of the baseline. According to these different definitions elective caesarean sections gave incidences for hypotension between 7.4% and 74.1%. In addition to its adverse effects on the mother, hypotension harmfully affects the fetus through a reduction of placental perfusion which may provoke an acute fall in intervillous blood flow leading to fetal academia and may be cardiac arrest. Several strategies are in use to combat hypotension accompanying spinal anesthesia in cesarean section of them is volume loading (pre or coloading) by using either crystalloids or colloids. Comparing pre-hydration versus co-hydration using crystalloids and colloids several recent studies have shown that hemodynamic changes and vasopressor requirements are the same. Despite similar effects of ephedrine and phenylephrine on the prevention and treatment of hypotension in pregnant women during spinal anaesthesia, administration of phenylephrine was associated with a lower incidence of foetal acidosis and maternal nausea and vomiting, making it the preferred vasoconstrictor in obstetric anaesthesia
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 04/05/2020
Actual trial start date 05/05/2020
Anticipated date of last follow up 13/08/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 140
Actual target sample size (number of participants)
Recruitment status 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,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group oral caffeine premedication once, 200 mg caffeine tablet 2 hours before spinal anaesthesia. once Patients will be randomly assigned using randomized code (by double blind technique) into: Caffiene group (C) (n=70) will receive 200 mg caffeine tablets 2 hours before spinal anaesthesia. Patient codes will be placed into sequentially numbered sealed opaque envelopes by a research assistant who is not involved in the study. Anesthesia technique: In the holding area, after history taking and clinical examination, baseline vital signs will be recorded. Just before premedication baseline blood pressure readings will be taken in the supine position estimated as the mean of three consecutive readings at 2-min intervals with a difference of less than 10%. After insertion of two peripheral 18-gauge lines patients will be premedicated with metoclopramide (10 mg intravenous) and ranitidine (50 mg intravenous). The study drug will be given with a sip of water by an anaesthetic resident who is not involved in the study or care of the patient. The foetal heart rate will be intermittently auscultated using handheld sonicaid before the premedication and regularly after premedication till giving the intrathecal anaesthesia. 500 ml lactated ringer will be infused rapidly just before the intrathecal anesthesia as a preload to be followed by 1000 ml coload then 10 ml/kg/hr for the remaining intraoperative time. Patients will receive intrathecal anaesthesia (hyperbaric bupivacaine 12.5 mg in addition to fentanyl 25 μg) at L3–L4 or L4–L5 interspace using a 27-gauge spinal needle B Braun medical, Germany) in the sitting position through a midline approach after careful sterilization. Oxygen (2-4 L/min) will be supplied by face mask after getting the patient supine with left uterine displacement. Both patient and anesthetist performing the block will be blinded to the study drug. The sensory block wi 70
Control Group multivitamin placebo tablet once, 2 hours before the intrathecal anesthesia for cesarean section once Patients will be randomly assigned using randomized code (by double blind technique) into: • Control group (P) (n=70) will receive placebo tablets (tablets identical to caffeine tablets). Patient codes will be placed into sequentially numbered sealed opaque envelopes by a research assistant who is not involved in the study. Anesthesia technique: In the holding area, after history taking and clinical examination, baseline vital signs will be recorded. Just before premedication baseline blood pressure readings will be taken in the supine position estimated as the mean of three consecutive readings at 2-min intervals with a difference of less than 10%. After insertion of two peripheral 18-gauge lines patients will be premedicated with metoclopramide (10 mg intravenous) and ranitidine (50 mg intravenous). The study drug will be given with a sip of water by an anaesthetic resident who is not involved in the study or care of the patient. The foetal heart rate will be intermittently auscultated using handheld sonicaid before the premedication and regularly after premedication till giving the intrathecal anaesthesia. 500 ml lactated ringer will be infused rapidly just before the intrathecal anesthesia as a preload to be followed by 1000 ml coload then 10 ml/kg/hr for the remaining intraoperative time. Patients will receive intrathecal anaesthesia (hyperbaric bupivacaine 12.5 mg in addition to fentanyl 25 μg) at L3–L4 or L4–L5 interspace using a 27-gauge spinal needle B Braun medical, Germany) in the sitting position through a midline approach after careful sterilization. Oxygen (2-4 L/min) will be supplied by face mask after getting the patient supine with left uterine displacement. Both patient and anesthetist performing the block will be blinded to the study drug. The sensory block will be assessed by cold alcohol swap along the midclavicular line bilaterally with the tar 70 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
normotensive patients aged 18-45 years (ASA physical status I-II, BMI>18 and <35 Kg/m2 with full term uncomplicated singleton pregnancy scheduled for elective caesarean delivery under spinal anaesthesia • Base line systolic blood pressure (SBP) less than 100 mmHg, • Pre-eclamptic patients, • Cardiac disease liver diseade kidney diseases. • Peptic ulcer disease or gastroesophageal reflux disease, • Severe anxiety • History of or any other neurological problem. • Allergy to amide local anesthetics or sensitivity to caffeine • Habitual coffee and other caffeinated beverages consumers. • Use of caffeine and other caffeine containing tablets or beverages or methyl xanthines within 2 days prior to the study. • Any contraindication of regional anesthesia, or patient refusal. • Suspicion of abnormal placentation. • Intrauterine growth restriction or fetal compromise Adult: 19 Year-44 Year 19 Year(s) 45 Year(s) Female
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 03/05/2020 faculty of medicine menoufia university egypt
Ethics Committee Address
Street address City Postal code Country
25 yassin abdelghaffar street shebin elkom 32511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Incidence of hypotension (SAP<90 mmHg or <80% of base line whichever is greater) after spinal anesthesia until end of surgery). from spinal to the end of the last skin stich
Secondary Outcome Time to onset of first post spinal hypotension episode . right after spinal anesthesia until end of surgery
Secondary Outcome Magnitude, duration and number of hypotension episodes . all through the intraoperative course before and after delivery
Secondary Outcome Number of rescue vasopressor boluses all through the intraoperative course before and after delivery
Secondary Outcome Vasopressor consumption from the end of intrathecal injection until delivery.
Secondary Outcome Vasopressor consumption from delivery until the end of surgery.
Secondary Outcome Neonatal APGAR score at 1 min and at 5 min post-delivery
Secondary Outcome Umbilical cord blood gases and base excess . An arterial pH value under 7.20 will be considered as acidosis. at 1 and 5 min post-delivery
Secondary Outcome hemodynamic side effects reactive hypertension systolic blood pressure > 120% of baseline will be considered all through the intraoperative course
Secondary Outcome Bradycardia defined as a pulse rate of < 60 beat/min. all through the intraoperative course
Secondary Outcome reactive tachycardia increase of the heart rate > 100 bpm of baseline all through the intraoperative course
Secondary Outcome intraoperative nausea, vomiting, dysrythmias all through the intraoperative course
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
anesthesia department faculty of medicine menoufia university egypt 25 yassin abdelghaffar street shebin elkom menoufia egypt 32511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Authors 25 yassin abdelghaffar st Shebin elkom Menoufia Egypt 32511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor anesthesia and intensive care department faculty of medicine menoufia university 5 yassin abdelghaffar street shebin elkom 32511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
khaled mohamed gaballah 25 yassin abdelghaffar street shebin elkom 32511 Egypt
sabry ibrahim abdallah 25 yassin abdelghaffer street shebin elkom 32511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator khaled gaballah khgaballah@gmail.com 00201016009073 25 yassin abdelghaffar street
City Postal code Country Position/Affiliation
shebin elkom 32511 Egypt lecturer of anesthesia and intensive care
Role Name Email Phone Street address
Public Enquiries sabry abdallah sabryabdallah222@yahoo.com 00201012378888 25 yassin abdelghaffar street
City Postal code Country Position/Affiliation
shebin elkom 32511 Egypt lacturer of anaesthesia and intensive care
Role Name Email Phone Street address
Scientific Enquiries khaled gaballah khgaballah@gmail.com 00201016009073 25 yassin abdelghaffar street
City Postal code Country Position/Affiliation
shebin elkom 32511 Egypt lecturer of anesthesia and intensive care
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes demographic data ( age, weight, height,), incidence of hypotension, Time to onset of first post spinal hypotension episode (right after spinal anesthesia until end of surgery). Magnitude, duration and number of hypotension episodes before and after delivery. Number of rescue vasopressor boluses before and after delivery. Vasopressor consumption from the end of intrathecal injection until delivery. Vasopressor consumption from delivery until the end of surgery. A systolic blood pressure > 120% of baseline will be considered reactive hypertension. Bradycardia defined as a pulse rate of < 60 beat/min. Delivery time (intrathecal injection till clamping the umbilical cord) An increase of the heart rate > 100 bpm of baseline will be considered reactive tachycardia. Dysrhythmias. Neonatal APGAR score at 1 min and at 5 min post-delivery. Umbilical cord blood gases and base excess at 1 and 5 min post-delivery. A bedside blood gas analysis will be performed using point-of-care testing. An arterial pH value under 7.20 will be considered as acidosis. Incidence of intraoperative nausea/vomiting. Informed Consent Form,Statistical Analysis Plan,Study Protocol the study time frame upon request
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