| CTRI Number |
CTRI/2008/091/000182 [Registered on: 03/10/2008] |
| Last Modified On: |
26/09/2012 |
| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
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| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
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A study to evaluate how effective it is to add Sufentanil to Propofol in intravenous anaesthesia for patients undergoing laparoscopic cholecystectomy |
Scientific Title of Study
Modification(s)
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A Comparison of Total Intravenous Anaesthesia using Propofol infusion with or without Sufentanil in laparoscopic cholecystectomies |
| Trial Acronym |
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Secondary IDs if Any
Modification(s)
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| Secondary ID |
Identifier |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
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| Name |
Borra Sreelakshmi |
| Designation |
|
| Affiliation |
|
| Address |
215, Department of Anaesthesiology
Global Hospitals, Lakdi-ka-pool
Hyderabad
ANDHRA PRADESH
500004
India |
| Phone |
|
| Fax |
|
| Email |
sree.borra@gmail.com |
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Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Borra Sreelakshmi |
| Designation |
|
| Affiliation |
AP Medical Council Reg. No: 47952, DNB (Anaesthesiology) resident, Global Hospitals, Hyderabad |
| Address |
215, Department of Anaesthesiology
Global Hospitals, Lakdi-ka-pool
Hyderabad
ANDHRA PRADESH
500004
India |
| Phone |
|
| Fax |
|
| Email |
sree.borra@gmail.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Borra Sreelakshmi |
| Designation |
|
| Affiliation |
|
| Address |
215, Department of Anaesthesiology
Global Hospitals, Lakdi-ka-pool
Hyderabad
ANDHRA PRADESH
500004
India |
| Phone |
|
| Fax |
|
| Email |
sree.borra@gmail.com |
|
Source of Monetary or Material Support
Modification(s)
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| Department of Anaesthesiology, Global Hospitals, Lakdi-ka-pool, Hyderabad- 500004, A.P., India |
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Primary Sponsor
Modification(s)
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| Name |
DrM Subrahmanyam |
| Address |
Head of the department, Department of Anaesthesiology, Global Hospitals, Lakdi-ka-pool, Hyderabad- 500004, A.P., India. E-mail: msubrah@gmail.com |
| Type of Sponsor |
Private hospital/clinic |
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Details of Secondary Sponsor
Modification(s)
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Countries of Recruitment
Modification(s)
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India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. M. Subrahmanyam |
Global Hospitals |
1-6-1070/1 to 4,Lakdi-ka-pool-500004
Hyderabad
ANDHRA PRADESH |
9246160977
msubrah@gmail.com |
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Details of Ethics Committee
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| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, Global Hospitals, Lakdi-ka-pool, Hyderabad-500004 |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
To compare and evaluate the effectiveness of different concentrations of Sufentanil mixed in Propofol infusion on perioperative haemodynamic parameters, recovery times and postoperative analgesia in total intravenous anaesthesia (TIVA) for patients undergoing laparoscopic cholecystectomy. , |
|
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Comparator Agent |
Plain Propofol infusion without any Sufentanil added |
Throughout duration of anaesthesia |
| Intervention |
Sufentanil added to Propofol infusion at different concentrations as total intravenous anaesthesia |
Group S1 received Sufentanil added to propofol at 1mcg/ml concentration of Sufentanil while group S2 received at 2 mcg/ml concentration throughout the duration of surgery |
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Inclusion Criteria
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| Age From |
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| Age To |
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| Gender |
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| Details |
Adult patients aged between 18 and 65 years of both sexes, of American Society of Anaesthesiologists (ASA) physical status I or II with airway status - Mallampati scores 1 and 2, posted for elective laparoscopic cholecystectomy
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| ExclusionCriteria |
| Details |
Age less than 18 years or more than 65 years, body weight more than 90 kgs, ASA physical status III to V, Mallampati scores 3 and 4 of airway, history of hypertension, history of coronary artery disease, history of long term analgesic use, history of psychiatric disorders, patients with severe hepatic or renal dysfunction and patients in whom NSAIDS are contraindicated. |
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Method of Generating Random Sequence
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Random Number Table |
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Method of Concealment
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Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
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Participant, Investigator and Outcome Assessor Blinded |
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Primary Outcome
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| Outcome |
TimePoints |
| Recovery time from anaesthesia |
Towards the end of anaesthesia for each patient undergoing surgery |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
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Target Sample Size
|
Total Sample Size="60"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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Phase 4 |
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Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
26/06/2006 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
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Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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This study is a randomised double blind study that evaluates the effectiveness of different concentrations of Sufentanil mixed in Propofol infusion in total intravenous anaesthesia (TIVA) for laparoscopic cholecystectomy. The objectives are to compare and evaluate perioperative haemodynamic parameters, recovery times and postoperative analgesia among 60 adult patients divided into three groups of 20 each receiving TIVA using Propofol infusion with or without Sufentanil. It was conducted over a period of 18 months at Global hospitals, Hyderabad. We conclude that both concentrations of Sufentanil added to Propofol infusion, 1 mcg/ml (Group S1) and 2 mcg/ml (Group S2), provide stable intraoperative haemodynamics and good postoperative analgesia. Recovery time was prolonged in Group S2 but it may not be clinically important (7 minutes). Hence,we conclude that both concentrations of Sufentanil achieve the goals of stable haemodynamics without a clinically significant prolongation of recovery time but the 24- hour postoperative analgesia was better in Group S2. |