Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
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Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201907779292947 Date of Approval: 16/07/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of ketamine infusion on postoperative mood scores in patients undergoing D&C. A randomized double blinded controlled study
Official scientific title Effect of ketamine infusion on postoperative mood scores in patients undergoing D&C. A randomized double blinded controlled study
Brief summary describing the background and objectives of the trial Emotional and psychological effects following abortion are more common than physical side effects and can range from mild regret to more serious complications such as depression. Research published in 2011 concluded that there was a "moderate to highly increased risk of mental health problems after abortion." The researchers suggested that undergoing a termination increased the risk by 81 percent and attributed 10 percent of this risk to the termination itself. Women with a higher probability of having a negative emotional or psychological side effect include: Individuals who obtain an abortion in the later stages of pregnancy, Individuals without support from significant others or their partner, Women obtaining an abortion for genetic or fetal abnormalities [1] The Profile of Mood States (POMS) is a psychological rating scale published in 1971 used to assess transient, distinct mood states. This scale was developed by McNair, Droppleman, and Lorr [2]. The first edition of the Profile of Mood States scale is known as the POMS-Standard version or the POMS-long form. Multiple short versions were published later after rigorous validation processes. Advantages of using this assessment include the simplicity of administration and ease of participant understanding. POMS test allowed both positive and negative states to be measured and observed in a clinical setting. Furthermore, it may be used to measure the effectiveness of treatments such as, various psychotropic drug treatments. [3] Recent studies suggest that a single low-dose administration of ketamine can provide within a few minutes of its initiation a long-lasting effect on mood [4]. Ketamine has emerged as a rapid powerful antidepressant and anxiolytic with enduring effects that last a week after a single subanaesthetic dose in the range of 0.3 to 0.5mg/kg however, its underlying mechanisms are not clear [5] Interestingly, the half-life of ketamine is only 3 h, suggesting that its antidepressant effect is unrelated to continuous blocking of N-methyl-d-aspartate (NMDA) receptors; instead, ketamine may mediate synaptic plasticity to cause long-term behavioral changes [6].
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Mental and Behavioural Disorders,Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 19/07/2019
Actual trial start date 20/07/2019
Anticipated date of last follow up 31/08/2020
Actual Last follow-up date 31/08/2020
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Completed
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Control Group Group C: patients received 50 ml normal saline over a period of 20 minutes. 20 minutes The women were randomized to 2 groups: C (Control group) and K (Ketamine group) using random number tables. The assigned treatments were written on cards and sealed in secure opaque envelopes numbered in sequence. On the scheduled time of operation, the head nurse (who was not part of the study) opened each envelope just before surgery, prepared the infusion solution and handled it to the anesthesiologist who was blinded to the solution. He was then determined for collecting perioperative data. Group C: patients received 50 ml normal saline over a period of 20 minutes. 30 Placebo
Experimental Group Ketamine Group Group K: patients received 0.4 mg/kg ketamine diluted in 50 ml normal saline over 20 min 20 minutes The women were randomized to 2 groups: C (Control group) and K (Ketamine group) using random number tables. The assigned treatments were written on cards and sealed in secure opaque envelopes numbered in sequence. On the scheduled time of operation, the head nurse (who was not part of the study) opened each envelope just before surgery, prepared the infusion solution and handled it to the anesthesiologist who was blinded to the solution. He was then determined for collecting perioperative data. Group K: patients received 0.4 mg/kg ketamine diluted in 50 ml normal saline over 20 min 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
18 years or older, physical status ASA I&II, with up to 12-week gestation, submitted to manual intrauterine aspiration for incomplete or retained abortion, participated in this randomized, double blind study. patients with infected abortion or with psychiatric disorder on chronic medical treatment. Also, patients with pulmonary, hepatorenal, neuromuscular diseases body mass index over 30 kg/m2, usage of sedative drugs or substance abuse, any contraindications to regional anesthesia and finally emergency curettage for massive bleeding or hemodynamic instability Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 60 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 10/07/2019 Research Ethics Committee REC
Ethics Committee Address
Street address City Postal code Country
Abbasia Cairo 11591 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Our primary outcome is mood changes which were assessed preoperatively and 2 h postoperatively with POMS-A to determine if there were differences in mood state that could be attributed to the interventional drug infused. preoperatively and 2 h postoperatively
Secondary Outcome Secondary outcomes were: 1. Mean blood pressure and heart rate were measured preoperatively then every 5 min till end of the operation. Postoperatively, mean blood pressure, heart rate, were recorded every 30 minutes for 2 hours in PACU 2. Total dose of ketamine infused. 3. The duration of surgery in minutes. 4. Presence of psychedelic’ phenomenon [10] intraoperatively (during infusion) and/or postoperatively. It is a temporary altered state of consciousness that might be induced by ketamine infusion. The subjective phenomenon that might be reported included one or more of the following: perceptual disorders, a sense of detachment from their bodies (dissociation), a sense of relaxation or well-being. Hallucinations, if occurred would be treated with injecting 2 mg intravenous midazolam. 5. Presence of intraoperative (during infusion) and/or postoperative other side effects as headache & diplopia 6. Presence of intraoperative (during infusion) and/or postoperative nausea and vomiting (PONV) which was rated on a 4-point scale (0=no PONV, 1=Mild nausea, 2=Severe nausea, 3=Vomiting). If PONV scale was 2 or more, ondansetron 4mg was given intravenously. 7. The patient satisfaction was assessed postoperatively at the 2nd hour. Patient satisfaction were rated on a scale of 1 to 4 (1=perfect, 2=good, 3=moderate, 4=bad). 8. Assessment of postoperative pain was done with the aid of visual analogue scale (VAS) in which patients were requested to estimate their pain on vertical VAS 0–10 cm where (0) is marked as no pain and (10) is marked as the worst pain ever felt. [11]. This was recorded postoperatively at specific timings: every 30 minutes for 2 hours postoperatively. 30 mg ketorolac was given intravenously if VAS score was > or equal to 4 at any of the mentioned times (with a maximum total ketorolac dose of 60 mg). 9. Assessment of perioperative sedation level using Sedation scale using University of Michigan Sedation Scale (UMSS) [12] The UMSS as a measure of sedation during procedures. The UMSS is a simple observational tool that assesses the level of alertness on a five-point scale ranging from 1 (wide awake) to 5 (unarousable with deep stimulation). Table (1) It will be assessed intraopertively till the 2nd postoperative hour; every 30 minutes. preoperatively and 2 h postoperatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain Shams University hospital Abbaseya Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ashraf Nabil Raham Hasan Mohamed Abdulmohsen Abdulnaiem Ismaiel Abbasiya Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ain Shams University Abbasiya Cairo Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Ashraf Nabil Saleh 5th Settlement Cairo Egypt
Raham Hasan Mostafa Nasr City Cairo Egypt
Mohamed Abdulmohsen Abdulnaiem Ismaiel Heliopolis Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Raham Hasan Mostafa rahamhasan@yahoo.com 01222530020 Nasr City
City Postal code Country Position/Affiliation
Cairo Egypt Assistant professor Ain Shams University
Role Name Email Phone Street address
Public Enquiries Mohamed Abdulmohsen Abdulnaiem Ismaiel mohamedismaiel79@gmail.com 01001381193 Heliopoless
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer of Anesthesia Ain Shams University
Role Name Email Phone Street address
Scientific Enquiries Ashraf Nabil Saleh ashraf_nabel@med.asu.edu.eg 01001100613 5th Settlement
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer of Anesthesia Ain Shams University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Excel Sheet Statistical Analysis Plan Twelve months Only journal editors to whom manuscript will be applied to
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Not Available 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