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.: PACTR202310522512402 Date of Approval: 10/10/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of three modalities on emergence agitation among post-traumatic stress disorder patients undergoing laparoscopy :RCT
Official scientific title Effect of three modalities on emergence agitation among post-traumatic stress disorder patients undergoing laparoscopy :A Randomized Controlled Study
Brief summary describing the background and objectives of the trial The emergence from anesthesia is the stage of general anesthesia where the patient restores consciousness. Patients cannot be considered fully recovered from anesthesia until they have returned to their preoperative physiological state. Awakening is involved with a range of domains other than anesthetic effect termination.. The postoperative quality recovery scale measures six determinants of recovery from immediate to long-term periods in patients, namely; physiologic, nociceptive, emotive, daily life activities, cognitive, and patient perspective satisfaction.Clinically emergence agitation (EA), also, referred to as emergence delirium involves restlessness, disorientation, excitation, non-purposeful movement, inconsolability, thrashing, and incoherence during early recovery from general anesthesia. Post-traumatic stress disorder (PTSD) is a disabling psychiatric disorder. The disorder follows a traumatic experience that involves threat to ones’ own life or physical integrity, is associated with witnessing death, injury, or threat to the physical integrity of another person. Symptoms of PTSD present in the form of recurrent, unpleasant, distressing memories and/or dreams that may be accompanied by persistently re-experiencing the traumatic event, intrusive thoughts, nightmares, flashbacks, dissociation intense sadness and guilt with physiological reaction on being exposed to the traumatic reminder. Therefore, if PTSD is detected preoperative, this could predict the occurrence of agitation during emergence, that if managed well, this would help to reduce its adverse consequences. The aim of this research is to Compare between three different intervention techniques used for avoiding emergence agitation in post-traumatic stress disorder (PTSD) patients undergoing gynecological laparoscopic surgery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Post-Traumatic Stress Disorder PTSD
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/01/2023
Actual trial start date 01/01/2023
Anticipated date of last follow up 31/10/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 144
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
Publication URL N/A
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
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Breathing exercise N/A Preoperative Patients will receive per-operative relaxation exercises :1-breathing ( deep inhalation through the nose then slow exhalation through the mouth followed by 2 normal breathes before repetition) and progressive muscle contraction(during inhalation)-relaxation(during exhalation). 36
Experimental Group Ketamin 0.5 mg/kg During induction of anesthesia Ketamin will be injected intravenous with induction 36
Experimental Group Breathing exercise and ketamin 0.5 mg/kg ketamin Breathing exercise Preoperative ketamine during induction of anesthesia Patients will receive per-operative relaxation exercises :1-breathing ( deep inhalation through the nose then slow exhalation through the mouth followed by 2 normal breathes before repetition.) and progressive muscle contraction(during inhalation)-relaxation(during exhalation). And Ketamin will be injected intravenous with induction of anesthesia 36
Control Group Control N/A N/A N/A 36 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Women in the reproductive age - Scheduled for gynecological laparoscopy for benign pathology - Positive screening for post-traumatic stress disorder. - Medical history for pelvic inflammatory disease associated or not associated with chronic pelvic pain - Major neurological, cardiovascular, metabolic, respiratory or renal disease. - History of chronic abdominal pain. - Use of psychiatric drugs. - History of comorbidities that may have an influence on post-operative nausea and vomiting (PONV) like diseases. Adult: 19 Year-44 Year 18 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 17/11/2022 The Ethics Committee of the Faculty of Medicine Alexandria University IRB No 00012098
Ethics Committee Address
Street address City Postal code Country
17 Champollion Street, El Messalah Alexandria 21521 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Riker sedation–agitation scores Immediately postoperative
Secondary Outcome VAS pain score Immediately postoperative and for the first 24 hours
Secondary Outcome Heart rate Intraoperative every 15 minutes and first day postoperative every 4 hours
Secondary Outcome Mean arterial blood pressure Intraoperative every 15 minutes and first day postoperative every 4 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
El Shatby Hospital for Obstetrics and Gynecology Suez Canal Road Al Shatebi Bab Sharqi Alexandria 21526 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ahmed mohmed ahmed elshafie Elkhortoum Square, Faculty of medicine, Alexandria University Alexandria 21532 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of Anesthesia Elkhortoum Square, Faculty of medicine, Alexandria University Alexandria 21532 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ahmed mohmed ahmed elshafie Elkhortoum Square, Faculty of medicine, Alexandria University Alexandria 21532 Egypt
Heba ahmed Abdelaziz 169 ElHoryia Road, Al Ibrahimeyah Qebli, Al Hadrah Bahri, Bab Sharqi Alexandria 21524 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Elshafie Ahmed.elshafie@alexmed.edu.eg 00201001962672 Elkhortoum Square, Faculty of medicine, Alexandria University
City Postal code Country Position/Affiliation
Alexandria 21524 Egypt Lecturer of Anesthesiology and Intensive Care Faculty of Medicine Alexandria University Egypt
Role Name Email Phone Street address
Scientific Enquiries Heba Abdelaziz Hiph.hebamahmoud@alexu.edu.eg 00201001448534 169 Horyia Road, Al Ibrahimeyah Qebli, Al Hadrah Bahri, Bab Sharqi
City Postal code Country Position/Affiliation
Alexandria 21524 Egypt Lecturerof Mental Health High Institute of Puplic Health Alexandria University
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Patient Information Manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual data will be available (including data dictionaries) All of the individual participant data collected during the trial, after de-identification. Study protocol and informed consent form will be available Data will be available: - Immediately following publication with no end date. - For anyone who wishes to access the data - For any type (purpose) of analyses - Upon proposal(s) that should be directed to elsayedamr@yahoo.com Informed Consent Form,Study Protocol Immediately following publication. No end date. Proposals should be directed to elsayedamr@yahoo.com Open access will be permitted to get the data please send an e-mail to elsayedamr@yahoo.com (public relations) Researchers decided to send data when requested No quality of request is required
URL Results Available Results Summary Result Posting Date First Journal Publication Date
N/A 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