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.: PACTR201910617459894 Date of Approval: 25/10/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Anti-inflammatory effect of ketamine versus dexmedetomidine in laparoscopic hysterectomy
Official scientific title Effects of intraoperative ketamine versus dexmedetomidine on release of inflammatory mediators in laparoscopic hysterectomy. Prospective randomized trial.
Brief summary describing the background and objectives of the trial Many postoperative complications appear to be caused by an exaggerated systemic pro-inflammatory response to surgical trauma. The systemic release of inflammatory mediators may lead to auto-destruction of the host through secondary damage to tissues/organs not originally affected by the primary injury. Ketamine is an old anesthetic drug characterized by interactions with numerous receptor systems.In the past 15 years, it has been reported to possess several new clinically beneficial properties such as anti-inflammatory actions. Although, ketamine anesthesia is associated with cardiovascular hyperdynamics and disturbing emergence reactions.Dexmedetomidine is a highly selective and potent α2 adrenergic agonist that is increasingly being used as an adjunct for general anesthesia due to its sedative/hypnotic and analgesic effects. In recent years, its anti-inflammatory effects have been highlighted. Studies in animals and clinical trials in intensive care patients have shown that dexmedetomidine can reduce cytokine secretion, which subsequently alleviates inflammation and reduces mortality. The aim of this study is to evaluate the effect of ketamine versus dexmedetomidine on attenuation of inflammatory cytokines release in laparoscopic hystrectomy surgeries.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Urological and Genital Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 10/11/2019
Actual trial start date
Anticipated date of last follow up 10/05/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 75
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 Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group general anesthesia only induction is done by fentanyl 1µg /kg, propofol 2mg/kg and cisatracurium 0.15 mg/kg to facilitate endotracheal intubation general anesthesia with controlled ventilation during the operation duration of the surgery Anesthesia is maintained by isoflurane 1.5-2% in 100% oxygen and cisatracurium 0.03mg/kg as required and ventilator settings are adjusted to keep EtCO2 between 35 and 40 mmHg. Blood sample will be withdrawn immediately after induction of anesthesia before skin incision to determine base line value of (tumor necrosis factor‑alpha [TNF‑α], IL‑6, CRP) which will be used as inflammatory biomarkers. 25 Placebo
Experimental Group ketamine racemic ketamine 0.25 mg/kg as intravenous bolus dose over 10 min then intravenous infusion at rate of 250 µg/kg/h ketamine will be given after induction of anesthesia and before skin incision. general anesthesia will be the same as the control group.Blood sample will be withdrawn immediately after induction of anesthesia before giving ketamine to determine base line value of (tumor necrosis factor‑alpha [TNF‑α], IL‑6, CRP) which will be used as inflammatory biomarkers. 25
Experimental Group dexmedetomidine dexmedetomidine initial intravenous dose of 1 µg/kg dexmedetomidine over 10 min then intravenous infusion rate of 0.5 µg/kg/h. dexmedetomidine will be given intraoperative after induction of anesthesia and before skin incision. general anesthesia will be the same as control group.Blood sample will be withdrawn immediately after induction of anesthesia before giving dexmedetomidine to determine base line value of (tumor necrosis factor‑alpha [TNF‑α], IL‑6, CRP) which will be used as inflammatory biomarkers. 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
seventy five female patients, aged 30-60, ASA physical status I –II, scheduled for elective laparoscopic hysterectomy patient refusal, severe respiratory or cardiac disorders, hepatic or renal insufficiency, allergy to any of the study drugs, severe obesity (body mass index >35 kg m−2), uncontrolled diabetes, use of any drug that might affect the immunity as chemotherapy or hormonal treatment. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 30 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 01/05/2019 Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Elgeish st Tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome assessment of the inflammatory mediators; tumor necrosis factor‑alpha (TNF‑α), interleukin 6 (IL‑6), and C-reactive protein (CRP) base line immediately after induction of anesthesia and before injection of the study drugs,then 6 and 24 hours after injection of the study drugs.
Secondary Outcome Mean arterial blood pressure and heart rate before induction of anesthesia,after intubation,after end of bolus infusion of study drugs,every 10 min until the end of the surgery.
Secondary Outcome Recovery time from discontinuation of anesthesia and reversal of muscle relaxant till transfer to PACU
Secondary Outcome Adverse effects: postoperative nausea and vomiting, over-sedation,bradycardia, hypotension, psychomimetic change as agitation, hallucinations, or vivid dreams up to 24 hours postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Facualty of Medicine El-Geish st Tanta 31527 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
authors Dr Mona Elghamry Dr Taysser AbdAlraheem and Dr Lamees Dawood Elgeish st Tanta 31527 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Lamees Mohamed Dawood Elgeish st Tanta 31527 Egypt Individual
Secondary Sponsor Dr Mona Raafat Elghamry Elgeish st Tanta 31527 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Mona Raafat El Ghamry Elgeish st Tanta 31527 Egypt
Taysser Mahmoud AbdAlraheem Elgeish st Tanta 31527 Egypt
Lamees Mohamed Dawood Elgeish st Tanta 31527 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mona El Ghamry drmonagh19802000@gmail.com +201060101867 Elgeish st
City Postal code Country Position/Affiliation
Tanta 31527 Egypt lecturer
Role Name Email Phone Street address
Scientific Enquiries Taysser AbdAlraheem Taysser.mahmoud@yahoo.com +201007592691 Elgeish st
City Postal code Country Position/Affiliation
Tanta 31527 Egypt lecturer
Role Name Email Phone Street address
Public Enquiries Lamees Dawood Bosbos193@yahoo.com +201225100563 Elgeish st
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Assistant professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes statistics of age ,sex,BMI, duration of surgery, inflammatory mediators,recovery time,hemodynamic parameter, and adverse events Statistical Analysis Plan IPD will be shared after finishing and publication of the study.and it will be available for 1 year. the IPD will be available for researchers up on e-mail request with reasons for which the data is requested. request will be sent to e-mail of principal investigator drmonagh19802000@gmail.com
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