| CTRI Number |
CTRI/2024/11/077217 [Registered on: 21/11/2024] Trial Registered Prospectively |
| Last Modified On: |
22/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of placement of a cotton pack in the oral cavity on stomach volume measured using an electronic device in patients undergoing routine surgery of the nose. |
|
Scientific Title of Study
|
Effect of throat pack on gastric volume measured using ultrasound in patients undergoing elective ENT procedures under controlled hypotensive anaesthesia with endotracheal intubation - A prospective randomized, double-blinded 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 |
Ghansham Biyani |
| Designation |
Associate Professor |
| Affiliation |
AIIMS mangalagiri |
| Address |
425, 4th floor, Department of Anaesthesiology, OPD building, All India Institute of Medical Sciences, Mangalagiri, Guntur, Andhra Pradesh
Guntur ANDHRA PRADESH 522501 India |
| Phone |
8764439671 |
| Fax |
|
| Email |
ghanshambiyani100@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Ghansham Biyani |
| Designation |
Associate Professor |
| Affiliation |
AIIMS mangalagiri |
| Address |
425, 4th floor, Department of Anaesthesiology, OPD building, All India Institute of Medical Sciences, Mangalagiri, Guntur, Andhra Pradesh
Guntur ANDHRA PRADESH 522501 India |
| Phone |
8764439671 |
| Fax |
|
| Email |
ghanshambiyani100@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Ghansham Biyani |
| Designation |
Associate Professor |
| Affiliation |
AIIMS mangalagiri |
| Address |
425, 4th floor, Department of Anaesthesiology, OPD building, All India Institute of Medical Sciences, Mangalagiri, Guntur, Andhra Pradesh
Guntur ANDHRA PRADESH 522501 India |
| Phone |
8764439671 |
| Fax |
|
| Email |
ghanshambiyani100@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS Mangalagiri |
| Address |
425, 4th floor, Department of Anaesthesiology, OPD building, All
India Institute of Medical Sciences, Mangalagiri, Guntur, Andhra Pradesh |
| Type of Sponsor |
Government 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 Ghansham Biyani |
AIIMS Mangalagiri |
425, 4th floor,
Department of
Anaesthesiology, OPD
building, All India
Institute of Medical
Sciences, Mangalagiri,
Guntur, Andhra Pradesh Guntur ANDHRA PRADESH |
08764439671 07073922403 ghanshambiyani100@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Mangalagiri Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group NTP without throat pack |
Patient scheduled to undergo elective FESS surgery under general anaesthesia with endotracheal intubation will be enrolled and subjected to controlled hypotensive anaesthesia without the insertion of any throat pack.
Patients will receive controlled hypotensive anaesthesia from the beginning to the end of surgery. |
| Comparator Agent |
Group TP with throat pack |
Patient scheduled to undergo elective FESS surgery under general anaesthesia with endotracheal intubation will be enrolled and subjected to controlled hypotensive anaesthesia with insertion of throat pack.
Patients will receive controlled hypotensive anaesthesia from the beginning to the end of surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I to III
BMI between 18.5 to 29.99 kg/m2
Scheduled to undergo elective FESS
Duration of surgery between 60 to 180 min.
|
|
| ExclusionCriteria |
| Details |
History of esophageal or gastrointestinal trauma or surgery
Patients with Diabetes mellitus, CKD and Pregnancy
Failure to obtain clear ultrasonographic images
Patients with anticipated difficult airway
Patients requiring more than one attempts at endotracheal intubation
Esophageal intubation
Occurrence of gastric content regurgitation or aspiration
Patients on drugs which affect the gastric motility like prokinetics and others
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in cross sectional area (CSA) of gastric antrum (measured using gastric ultrasound) and gastric volume (calculated using Perla’s equation) at the end of the procedure compared to preinduction in both the group.
At baseline and at the end of surgery (At 0 minutes, 60 or 120 minutes) |
Change in cross sectional area (CSA) of gastric antrum (measured using gastric ultrasound) and gastric volume (calculated using Perla’s equation) at the end of the procedure compared to preinduction in both the group (At 0 minutes, 60 or 120 minutes) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence and severity of sore throat using Four-point scale |
At 0, 30, 60 and 120 min |
| Incidence and severity of PONV using Kortilla’s scale |
At 0, 30, 60 and 120 min |
| Incidence of laryngospasm, bronchospasm and oxygen saturation |
At 0, 30, 60 and 120 min. |
|  Incidence of postoperative symptoms suggestive of gastric distention like bloating, burping, and flatulence |
At 120 min |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
01/08/2025 |
| 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)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [ghanshambiyani100@gmail.com].
- For how long will this data be available start date provided 01-01-2025 and end date provided 01-01-2029?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
1. Surgeries
of the nasal cavity are among the commonly performed otorhinolaryngology
procedures across the world. Insertion of a throat pack to minimise
trickling down of the blood into the trachea and esophagus is a commonly
practiced technique worldwide, despite emergence of literature evidence against
its use. [1] The common belief is that in the absence of insertion
of a pharyngeal pack, blood enters into the stomach and is a potent emetic
resulting in increased incidence of postoperative nausea and vomiting (PONV). [2]
Hence, surgeons often request for the insertion of a throat pack while
performing procedures like septoplasty and Functional Endoscopic Sinus Surgery
(FESS) so as to reduce gastric distension and thereby the incidence and
severity of PONV. It may also help the surgeons by providing a relatively dry
field to operate by absorbing blood and irrigation fluids used during the surgery.
However, recently published
recommendations are against the routine practice of placing throat packs. [1]
Insertion of pharyngeal packs increases the incidence and severity of
sore throat. [3, 4] Also, there is published literature comparing
the incidence of PONV with and without the insertion of throat pack and found
no difference in the incidence of PONV. [3] Moreover, the leftover
throat pack by mistake is a “never event’ (retained foreign body) and may
result in serios consequences including airway obstruction and hence, their
routine insertion is now being questioned. [1].
The major cause of bleeding in the
intraoperative period during FESS surgery under general anaesthesia (GA) is
attributed to peripheral vasodilatation and to surgical stimulus causing increases
in blood pressure and thereby bleeding. Better vascularity of the nasal cavity
also plays a minor role. To reduce intraoperative blood loss, many strategies
are used including the use of controlled hypotensive anaesthesia, infiltration
of nasal cavity with local anaesthetic and adrenaline, and slight head end
elevation by 10 to 15Ëš. Controlled
hypotensive anaesthesia by using pharmacological agents is a commonly practiced
and useful technique. Intravenous administration of Dexmedetomidine to provide
hypotensive anaesthesia is found to be effective in reducing intraoperative
bleeding. It also attenuates the response to surgical incision by providing analgesia.
All this may help in providing a relatively avascular field for the surgeons to
operate, thereby reducing the amount of irrigation fluid required in the
intraoperative period, resulting in lesser gastric distension.
Hence, we would like to assess the
gastric volume of the patients undergoing elective FESS
under controlled hypotensive anaesthesia with endotracheal intubation with
and without the insertion of throat pack. |