UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054257 |
|---|---|
| Receipt number | R000061961 |
| Scientific Title | Comparative Evaluation of effects of Dexmedetomidine and Magnesium Sulphate on Haemodynamic Parameters during Laparoscopic Cholecystectomy under General Anaesthesia |
| Date of disclosure of the study information | 2024/04/25 |
| Last modified on | 2024/04/25 17:38:17 |
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Basic information
Public title
Comparison of dexmedetomidine and magnesium sulphate in laparoscopic cholecystectomy
Acronym
DEXMED, LC, MG
Scientific Title
Comparative Evaluation of effects of Dexmedetomidine and Magnesium Sulphate on Haemodynamic Parameters during Laparoscopic Cholecystectomy under General Anaesthesia
Scientific Title:Acronym
DEXMED, LC, MG
Region
| Asia(except Japan) |
Condition
Condition
Symptomatic cholelithiasis
Classification by specialty
| Hepato-biliary-pancreatic surgery | Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study and compare the effects of intravenous single dose dexmedetomidine and magnesium sulphate on haemodynamic parameters in patients undergoing elective laparoscopic cholecystectomy under general anaesthesia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
To study and compare the effects of intravenous single dose dexmedetomidine and magnesium sulphate on haemodynamic parameters in patients undergoing elective laparoscopic cholecystectomy under general anaesthesia
Key secondary outcomes
ioflurane concentration, pain, post operative nausea and vomiting, sedation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients were given 100ml NS 0.9% IV (group NS, n=15) over a period of 10 minutes in double blinded manner after induction of anaesthesia but before creation of pneumoperitoneum
Interventions/Control_2
Patients were given Dexmedetomidine 1microgm/kg in 100ml NS (group DX, n=15) in double blinded manner after induction of anaesthesia but before creation of pneumoperitoneum
Interventions/Control_3
Patients were given or magnesium sulphate 50mg/kg in 100 ml NS (group MG, n=15) in double blinded manner after induction of anaesthesia but before creation of pneumoperitoneum
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
ASA (American Society of Ananesthesiologist) physical status-1,aged between 18-60 years of either sex undergoing elective laparoscopic cholecystectomy
Key exclusion criteria
Patients with history of cardiovascular disease, endocrine disease like uncontrolled diabetes mellitus, thyroid disorder, compromised renal, hepatic, neuronal functions, pregnant or lactating females or any patient taking drugs affecting cardiovascular parameters .
Conversion of laparoscopic to open cholecystectomy, excessive internal bleeding leading to hypotension or requiring blood transfusion or duration of pneumoperitoneum more than 2 hours
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | ANKITA |
| Middle name | |
| Last name | KAASAT |
Organization
Ananta Institute of Medical Sciences and Research Centre
Division name
DEPARTMENT OF ANAESTHESIA AND CRITICAL CARE
Zip code
313202
Address
NH-8, Rajsamand, Rajasthan(313202) , INDIA
TEL
6361854732
ankitakaasat@gmail.com
Public contact
Name of contact person
| 1st name | ANKITA |
| Middle name | |
| Last name | KAASAT |
Organization
Ananta Institute of Medical Sciences and Research Centre
Division name
DEPARTMENT OF ANAESTHESIA AND CRITICAL CARE
Zip code
313202
Address
NH-8, Rajsamand, Rajasthan(313202) , INDIA
TEL
6361854732
Homepage URL
ankitakaasat@gmail.com
Sponsor or person
Institute
University College of Medical Sciences AND GTB Hospital
Institute
Department
Personal name
Funding Source
Organization
University College of Medical Sciences AND GTB Hospital
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
INSTITUTIONAL ETHICAL COMMITTEE (IEC-HR), UNIVERSITY COLLEGE OF MEDICAL SCIENCES, UNIVERSITY OF DELHI
Address
TAHARPUR ROAD, GTB ENCLAVE,DILSHAD GARDEN, DELHI 110095, INDIA
Tel
91-11-22595974
iechrucms@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | Month | 25 | Day |
Related information
URL releasing protocol
NA
Publication of results
Unpublished
Result
URL related to results and publications
NA
Number of participants that the trial has enrolled
45
Results
During pneumoperitoneum significant reduction in heart and Systolic blood pressure of group Dexmdetomidine and Magnsium sulphate (more in group Dexmedetomidine) as compared to group Normal salinewas observed at all point of time. (p>0.05)
Results date posted
| 2024 | Year | 04 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The demographic parameters of all patients of three groups were comparable with no statistically significant difference (p>0.05). Total duration of pneumoperitoneumand intravenous fluids infused were similar in all three groups with no statistically significant difference
Participant flow
After getting approval from institutional ethical committee- human research (IEC-HR) and informed consent from each patient to participate in study, 45 patients of ASA physical status-1,aged between 18-60 years of either sex undergoing elective laparoscopic cholecystectomy were included in the study
Adverse events
All patients were monitored for the occurrence of any complications or side effects. Intraoperativebradycardia (HR<60 bpm) was noted in 1 (6.67%) patientof NS and MG groups each, while in the DX group it was observed in 6 (40%) patients. None of the patients had heart rate less than 50 bpm. Each episode responded well with injection atropine 0.3 mg IV. In DX group 9 out of 15 patients developed hypotension. Only 1 patient in NS and MG group each had systolic blood pressure less than 90 mmHg. All patients responded to IV fluid therapy and only 1 patient in DX group required 10 mg ephedrine to treat hypotension.
Outcome measures
To study and compare the effects of intravenous single dose dexmedetomidine and magnesium sulphate on haemodynamic parameters in patients undergoing elective laparoscopic cholecystectomy under general anaesthesia.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 11 | Month | 16 | Day |
Date of IRB
| 2013 | Year | 11 | Month | 27 | Day |
Anticipated trial start date
| 2014 | Year | 01 | Month | 08 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 04 | Month | 25 | Day |
Last modified on
| 2024 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061961
