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.: PACTR202311673887516 Date of Approval: 28/11/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Haloperidol versus Dexmedetomidine as an Adjuvant to Ondansetrone in Postoperative Nausea and Vomiting in Laparoscopic Cholecystectomy
Official scientific title Haloperidol versus Dexmedetomidine as an Adjuvant to Ondansetrone in Postoperative Nausea and Vomiting in Laparoscopic Cholecystectomy
Brief summary describing the background and objectives of the trial Despite the progression of the new anti-vomiting techniques, Postoperative nausea and vomiting (PONV) is still one of the most common complications after general anaesthesia especially after laparoscopic surgeries in the immediate 24 postoperative hours. No single antiemetic drug has been provided to be a universal solution to PONV. In this study we will compare between Dexmedetomidine vs low dose haloperidol as an adjuvant to ondansetron in reliefing postoperative nausea and vomiting after laparoscopic cholecystectomy.
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 Treatment: Drugs
Anticipated trial start date 01/05/2023
Actual trial start date 01/05/2023
Anticipated date of last follow up 21/12/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 75
Actual target sample size (number of participants)
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,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group groups receiving either haloperidol or dexmedetomidine combined with ondansetron 2mg of haloperidol combined with 4 mg ondansetrone or 0.5 µ/kg dexmedetomidine combined with 4mg ondansetrone Ten minutes before the end of surgery (at skin closure) Ten minutes before the end of surgery (at skin closure) patients will receive 1 g of IV paracetamol followed by the study drug according to the group allocation: Group H will receive 2mg of haloperidol combined with 4 mg ondansetrone Group D will receive a dose of 0.5 µ/kg dexmedetomidine combined with 4mg ondansetrone 50
Control Group group receiving only ondansetron without adjuvants 4 mg of ondansetrone Ten minutes before the end of surgery (at skin closure) this group will receive only 4 mg of ondansetrone 25 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Age (18 – 65) undergoing laparoscopic cholecystectomy. 2. American Society of Anesthesiologist (ASA)- physical status I & II 3. No history of psychiatric illness 4. No Parkinson's disease, motion sickness or history of chemotherapy 5. Both gender 1. Patients on (steroids, antiemetics, or any drug that may cause emesis). 2. Pregnancy. 3. Any active cardiac or chest condition at the time of surgery 4. ASA ≥ III and IV physical status 5. Parkinson's disease 6. Patients with psychiatric disease history 7. Patients on chemotherapy Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 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 21/12/2022 Research Ethical Comitee at Faculty Of Medicine Ain Shams University
Ethics Committee Address
Street address City Postal code Country
38 abassia square, next to al nour mosque cairo 1181 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome • Incidence of PONV in the 1st postoperative 24 hours immediately postoperative and for 24 hours
Secondary Outcome • The number of nausea and vomiting attacks. • Severity of postoperative nausea and vomiting using a 10 cmVAS score rating scale. • Use of rescue aniemetic • Assessment of postoperative pain using VAS score • The sedation scores (Observer’s Assessment of Alertness⁄Sedation (OAA⁄S) scale) (where 1 =awake⁄alert, 2=light sedation, 3=moderate sedation, 4=deep sedation and 5 = deep sleep) immediately postoperative until the patient is discharged home
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty Of Medicine Ain Shams University 38 Abbasia square, next to al nour mosque cairo 1181 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
The Principle Investigator 19, street 17, fifthe settlement cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty Of Medicine Ain Shams University 38 Abassia Square, Next to AL-Nour Mosque cairo Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mostafa Mohammed Abu Sekkien 158 , second district , fifthe settlement cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Mostafa Abu Sekkien mostafaig1236@hotmail.com +201097207140 street 17 villa 19, fifthe settlement
City Postal code Country Position/Affiliation
cairo Egypt Assistant Lecturer in Department of Anesthesia and Icu Ain shams University
Role Name Email Phone Street address
Scientific Enquiries Ahmed Abdelhak Ahmed.abdeldayem@med.asu.edu.eg +201229315279 shubra el kheima
City Postal code Country Position/Affiliation
cairo Egypt Lecturer of Anesthesia Ain Shams University
Role Name Email Phone Street address
Principal Investigator Ashraf Saleh Ashraf_nabil95@yahoo.com +201001100613 fifthe 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 All of the Individual data collected during the trial , after de-identification Study Protocol following publication Any purpose
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