Comparison Between Inhalational Anesthetic (Sevoflurane) and Intravenous Anesthetic (Propofol Infusion) for Maintenance of Sedation During Endoscopic Retrograde Cholangiopancreatography
Phase: PHASE4
Conditions: Sedation Complication
Sponsor: Sindh Institute of Urology and Transplantation

Comparison between inhalational anesthetic (sevoflurane) and 
intravenous anesthetic (propofol infusion) for maintenance of sedation 
during Endoscopic retrograde cholangiopancreatography 
 
 
 
 
 
 
 
 
 
Principle investigator  
Dr. Vijai Kumar  
Senior Lecturer  
Department of Anesthesiology SIUT Karachi 
Dated: 01-07-2021 
 
 
 
 
 
 
 

 
INTRODUCTION 
 
The number and complexity of gastrointestinal (GI) procedures is increasing rapidly [1]. Over 50 
million GI endoscopic procedures were performed in the United States alone in 2017, including 
approximately 19 million colonoscopies [2]. The complexity of endoscopic procedures has 
increased, By using this technique, a patient can get both advantages such as Therapeutic and 
Diagnostic. ERCP technique even made this procedure easier for patients who were at the high 
risk in conventional surgery [10]. It became a challenge for using the anesthetic technique with 
the changing status of patient periodically, in most of the cases sedation is widely used. Although 
it is a risky procedure, for that general anesthesia is necessary because of patients who are 
undergoing ERCP in Co-morbidities [7] Propofol is widely used agent for sedation for GI 
endoscopy [6]. Advantages of propofol include its rapid effect site equilibration and short 
elimination half-time even after prolonged infusion. Thus, the depth of sedation can be adjusted 
rapidly, and patients recover quickly without residual psychomotor effects. However, propofol 
has a narrow therapeutic index, meaning that patients may rapidly transition to deeper levels of 
sedation, including general anesthesia, and apnea, airway obstruction, hypoxemia and/or 
hypotension can result. Thus, propofol should be titrated to effect, and administered by clinicians 
who are able to manage airway and hemodynamic compromise.Sevoflurane is relatively new 
inhaled anesthetic that also permits rapid emergence due to its low blood solubility. It has been 
successfully used as an alternative to propofol for various day care procedures. 
OPERATIONAL DEFINATIONS 
SEDATION 
. A drug induced depression of consciousness during which patient can not be aroused easily but 
respond purposefully following repeated or noxious stimulation 
 
RECOVERY TIME 

• 
Time period from cessation of drugs to regain consciousness (Orientation to time and 
place)  
 
OBJECTIVE 
The aim of the study is to find out the comparison between two drugs of moderate sedation in 
patients undergoing ERCP. One drug is propofol and another one is sevoflurane. Both agents 
will be compared regarding sedation, hemodynamic changes in patients undergoing ERCP. For 
sedation we use Ramsay Sedation score. 
HYPOTHESIS: 
Propofol infusion will cause less hemodynamics instability than sevoflurane. 
 
MATERIAL AND METHOD: 
• 
Study design: Randomized Controlled trial study is used. 
• 
Study Setting: Department of Anesthesiology, Sindh institute of urology and 
transplantation (SIUT). 
• 
 Duration: 6 months after approval from ethical review committee of SIUT.  
• 
Sample size: Based on the previous estimate of hypotension in sevoflurane group was 
found in 33% of patients and 8.8% in propofol infusion group with power of 80% & 5% 
level of significance. A total no of 86 patients will be part of study, out of which 43 will 
be selected for each group. [11] 
INCLUSION CRITERIA: 
• 
Patients between age group of 20-60 years 
• 
Both male and female patients.  
• 
ASA status I-II  
• 
Elective ERCP procedure. 

EXCLUSION CRITERIA: 
• 
Patients allergic to any study drug. 
• 
ASA III-IV like Patients with uncontrolled DM, HTN and renal insufficiency.  
• 
BMI over 36 KG/m2 (Morbid obese) 
• 
Sleep Apnea 
• 
Gastroesophageal reflux disease (GERD) 
• 
Pregnancy  
DATA COLLECTION PROCEDURE 
This study will be conducted after approval of ethical committee of SIUT. For research 86 
patients will be selected for the elective ERCP. Pre-operative assessment will be taken such as 
history of patients, general physical examination, systematic examination, and laboratory 
investigations will be part of assessment. Patients will be divided in two groups based on agents 
used for the research study. Both the groups will be induced by injection midazolam 0.06 mg/kg 
and injection nalbuphine 0.1 mg/kg . Anesthesia will be maintained in……. 
Group A Sevoflurane inhalation to achieve MAC Amnesia 0.25%.  
Group B Propofol infusion at 50 ug/Kg/min.  
When Ramsay Sedation Scale 5 is achieved than surgeon will be allowed to insert endoscope. Inj 
Ketamine 0.5mg/kg will be used for Rescue sedation .Upon arrival in operation theatre standard 
monitoring which includes pulse oxymeter (SPO2), noninvasive blood pressure (NIBP), 
electrocardiogram (ECG) electrodes will be applied, and baseline readings will be recorded. 
After that venous access will be secured on a non-dominant hand by 20G IV cannula, i/v fluid 
(R/L or N/S) will then be started by 8 ml/kg/h and O2 will be given by nasal mask at 4 L/min. 
All baseline parameters will be taken, after that readings will be taken at 5 min, 10 min, 15 
min,20 min and so on till procedure ends. 

Complications such as respiratory depression, coughing, gagging, nausea and vomiting will be 
recorded during the procedure and treated accordingly. If SpO2 goes down below 92% for more 
than 10 seconds or patient develops apnea, it will be considered oxygen desaturation. 
 It will be managed by O2 inhalation and supporting airway. A heart rate under 40beats per 
minute will be considered bradycardia and it will be managed by inj Atropine 10 ug/Kg I/V. 
Mean arterial pressure level that is lower than 60 mmHg or 20% less than the baseline will be 
regarded as hypotension and it will be managed by fluid bolus or vasopressors.  
Complications such as respiratory depression, coughing, gagging, nausea and vomiting will be 
recorded and treated accordingly. After the procedure, patient will be awakened and shifted to 
HDU. 
DATA ANALYSIS: 
For data analysis SPSS software will be used of version 22. Mean and standard deviation will be 
computed for variable such as age, height, BMI, RSS, HR, SBP, DBP and MAP at 0,1,3,5,10 
min. For determining the differences in the hemodynamics mean unpaired “t” test will be used 
between groups. Categorically Variables such as gender, ASA and post op complications like 
gagging, PONV, Apnea and cough will be presented as frequencies and percentages.  
Chi-square test will be followed and used between 2 groups, there proportion difference will be 
compared using P value  
 
 
 
 
 
 
 
 

 
 
 
PERFORMA  
GROUP A                      GROUP  B 
 
CASE# 
  
DATE 
  
Serial # 
  
AGE 
YEARS 
SEX 
MALE        FEMALE  
WEIGHT 
KG  
HEIGHT 
Cm 
MALAMPATI SCORE 
 
  
ASA 
  
BMI 
Kg/m2 
 
 

 
 
 
 
Sedation monitoring 
SBP
DBP
MAP
mmHg mmHg mmHg
Base line
5 min
10 min
15 min
20 min
25 min
30 min
35 min
40 min
45 min
50 min
55 min
60 min
Respiratory Monitoring
Haemodynamic Monitoring
Time in min HR b/n
SpO2%
R/R/min END TIDAL CO2 Ramsay sedation score

 
COMPLICATION DURING AND AFTER ERCP 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

REFRENCES 
• 
Philip BK, Lombard LL, Roaf ER, Drager LR, Calalang I, Philip JH. Comparison of  
vital capacity induction with sevoflurane to intravenous induction with propofol for adult 
ambulatory anesthesia. Anesth Analg. 1999; 89:623–7. [PubMed] [Google Scholar] 
• 
Fish WH, Hobbs AJ, Daniels MV. Comparison of sevoflurane and total intravenous 
anaesthesia for daycare urological surgery. Anaesthesia. 1999; 54:999–1006. 
• 
75 Million Endoscopies Performed Annually According to iData Research Procedure 
Analysis. Available at https://idataresearch.com/75-million-endoscopies--performed- 
annually-according-to-idata-research-procedure-analysis/ (Accessed on February 04, 
2019). 
• 
Gourda BG, Singh PM, Penugonda LC, et all. Significantly reduced hypoxemic events in 
morbidity obese patients undergoing gastrointestinal endoscopy: Predictors and practice 
effect. J Anaesthesicol Clin Pharmacol 2014: 30: 71. 
• 
Ladas SD, Satake Y, Mostafa I, Morse J. Sedation practices for gastrointestinal 
endoscopy in Europe, North America, Asia, Africa and Australia. Digestion. 2010;82:74–
6 
• 
Mazanikov M, Udd M, Kylänpää L, et al. Patient-controlled sedation with propofol and 
remifentanil for ERCP: a randomized, controlledstudy. Gastrointest Endosc. 2011; 
73:260–266. 
• 
Mohammed, N., Cluff, K., Griffith, J., & Loflin, B. (2019). A noninvasive, 
electromagnetic, epidermal sensing device for hemodynamics monitoring. IEEE 
transactions on biomedical circuits and systems, 13(6), 1393-1404. 
• 
Salminen, P., Laine, S., & Gullichsen, R. (2008). Severe and fatal complications after 
ERCP: analysis of 2555 procedures in a single experienced center. Surgical endoscopy, 
22(9), 1965-1970. 
• 
Siegel JH, Kasmin FE. Biliary tract diseases in the elderly: management and outcomes. 
Gut. 1997; 41:433–435. 

• 
Motiaa, Y., Bensghir, M., Jaafari, A., Meziane, M., Ahtil, R., & Kamili, N. D. (2016). 
Anesthesia for endoscopic retrograde cholangiopancreatography: target-controlled 
infusion versus standard volatile anesthesia. Annals of Gastroenterology: Quarterly 
Publication of the Hellenic Society of Gastroenterology, 29(4), 530.