| CTRI Number |
CTRI/2025/09/094499 [Registered on: 10/09/2025] Trial Registered Prospectively |
| Last Modified On: |
09/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
PROSPECTIVE OBSERVATIONAL STUDY |
| Study Design |
Other |
|
Public Title of Study
|
Study on How Abdominal Pressure and Patient Position Affect Neck Vein Size During Laparoscopic Surgery |
|
Scientific Title of Study
|
Impact of Pneumoperitoneum pressure and patient positioning on the dimensions of the internal jugular vein during laparoscopic surgery-a prospective observational study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR HARISHMAA R |
| Designation |
PG student |
| Affiliation |
SRI VENKATESHWARA MEDICAL COLLEGE HOSPITAL AND RESEARCH INSTITUTE |
| Address |
Department of Anaesthesiology, Main OT complex,Room no.1
13-A,Pondy-Villupuram Main Road, Sri Venkateshwaraa Medical
College Hospital and Research Centre, Ariyur, Puducherry.
Pondicherry
Department of Anaesthesiology, Main OT complex,Room no.1,
13-A,Pondy-Villupuram Main Road, Sri Venkateshwaraa Medical
College Hospital and Research Centre, Ariyur, Puducherry.
Pondicherry
Pondicherry
PONDICHERRY
605102
India |
| Phone |
6380861052 |
| Fax |
|
| Email |
harishmaa123.4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR HARISHMAA R |
| Designation |
1 ST YEAR POSTGRADUATE |
| Affiliation |
SRI VENKATESHWARA MEDICAL COLLEGE HOSPITAL AND RESEARCH INSTITUTE |
| Address |
Department of Anaesthesiology, Main OT complex,Room no.1
13-A,Pondy-Villupuram Main Road, Sri Venkateshwaraa Medical
College Hospital and Research Centre, Ariyur, Puducherry.
Pondicherry
Pondicherry
PONDICHERRY
605102
India |
| Phone |
6380861052 |
| Fax |
|
| Email |
harishmaa123.4@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR HARISHMAA R |
| Designation |
1 ST YEAR POSTGRADUATE |
| Affiliation |
SREE VENKATESHWARA MEDICAL COLLEGE HOSPITAL AND RESEARCH INSTITUTE |
| Address |
Department of Anaesthesiology, Main OT complex,Room no.1
13-A,Pondy-Villupuram Main Road, Sri Venkateshwaraa Medical
College Hospital and Research Centre, Ariyur, Puducherry.
Pondicherry
Department of Anaesthesiology, Main OT complex,Room no.1,
13-A,Pondy-Villupuram Main Road, Sri Venkateshwaraa Medical
College Hospital and Research Centre, Ariyur, Puducherry.
Pondicherry
Pondicherry
PONDICHERRY
605102
India |
| Phone |
6380861052 |
| Fax |
|
| Email |
harishmaa123.4@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DR HARISHMAA R |
| Address |
Department of Anaesthesiology, Main OT complex,Room no.1,
13-A,Pondy-Villupuram Main Road, Sri Venkateshwaraa Medical
College Hospital and Research Centre, Ariyur, Puducherry.
Pondicherry |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR HARISHMAA |
Sri venketeshwara medical college and hospital |
Department of Anaesthesiology, Main OT complex,Room no.1,
13-A,Pondy-Villupuram Main Road, Sri Venkateshwaraa Medical
College Hospital and Research Centre, Ariyur, Puducherry.
Pondicherry
PONDICHERRY
605102
India
Pondicherry
PONDICHERRY |
6380861052
harishmaa123.4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K358||Other and unspecified acute appendicitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients posted for Laparoscopic surgery
Age 18-50 years of age of both genders
American Society of Anesthesiologists (ASA) (I & II)
|
|
| ExclusionCriteria |
| Details |
Cardiovascular disease
Severe chronic obstructive pulmonary diseases
Chest wall deformities
Pregnant and lactating womens
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of pneumoperitoneum and patient positioning on the cross-sectional area of the internal jugular vein in patients undergoing laparoscopic surgery. |
Before induction of anesthesia
5 min after intubation
5 min after pneumoperitoneum
5 min after positional change
5 min after desufflation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess impact of the venous return & its associated hemodynamic changes during laparoscopic surgical procedures.
To assess the intra operative complication.
|
Before induction of anesthesia
5 min after intubation
5 min after pneumoperitoneum
5 min after positional change
5 min after desufflation |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This prospective observational study evaluates the effect of pneumoperitoneum pressure and patient positioning on the cross sectional area of the internal jugular vein during laparoscopic surgery. A total of 52 adult patients aged 18 to 50 years with ASA class I and II undergoing elective laparoscopic surgery will be studied. Ultrasound measurements of the right internal jugular vein will be taken at five stages of surgery including before induction after intubation after pneumoperitoneum after positional change and after desuflation. Hemodynamic parameters such as heart rate blood pressure oxygen saturation and end tidal carbon dioxide will also be recorded. The study aims to determine how intra abdominal pressure and patient positioning influence venous return and cardiovascular function. Findings are expected to show significant alterations in vein dimensions and hemodynamic status which may help improve intraoperative monitoring and safer anesthetic management during laparoscopic procedures. |