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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  
AIIMS Mangalagiri 
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [ghanshambiyani100@gmail.com].

  6. 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.

  7. 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.

 
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