A study to evaluate the effects of different levels of air pressures in abdomen during various laparoscopic surgeries of kidney on physiology of patients during and after surgery

Not yet recruiting

• Conditions: Other intraoperative and postprocedural complications and disorders of genitourinary system,

• Registration Number: CTRI/2019/07/020114
• Lead Sponsor: Sanjoy Kumar Sureka

Brief Summary

The present study aims to define the optimal and safe pneumoperitoneal pressure in patients undergoing various transperitoneal laparoscopic renal surgeries at a tertiary care centre considering its effects on patient’s clinical parameters as well as technical feasibility for the surgeons.

This will be a prospective single blinded randomised study performed at a tertiary care teaching hospital in India of 3 months duration. Approximately 80 patients aged 18 years and above, undergoing any of the transperitoneal laparoscopic renal surgery (LRS) under general anesthesia will be included in the study. The study population will be randomized into three strata according to pneumoperitoneal pressure by computer-generated number (Group I pressure 8-10 mmHg, Group II pressure 10-12 mmHg and group III pressure 12-14 mmHg). Patients will be induced by general anesthesia. All patient’s hemodynamic and respiratory parameters and blood gas alterations will be assessed at four specific points during surgery: before insufflation (T1), 10 min after insufflation (T2), 10 min before desufflation (T3), and 10 min after desufflation (T4). The first set of parameters will be noted after induction of anesthesia after obtaining a steady state ventilation and prior to creating pneumoperitoneum (T1) including heart rate (HR), mean arterial pressure (MAP), pH, arterial O2 pressure(pO2), arterial CO2 pressure (pCO2), base excess (BE), end tidal CO2 (ETCO2), , and peak inspiratory pressure (PIP), plateau pressure (PlP) and minute ventilation (MV).

Then, the peritoneal cavity will be insufflated with CO2 after placing umbilical port under vision (Hasson’s technique) using electronic laparoscopic insufflators with an initial flow rate of 3-4 L/min. Other ports will be subsequently placed as per standard steps.

Further sets of same parameters will be recorded 10 min after insufflation (T2), 10 min before desufflation (T3) and 10 min after desufflation (T4) of the peritoneum. Technical feasibility from surgeon’s point of view will be evaluated in terms of successful completion of surgery without conversion to open method at planned pressure with acceptable duration of the surgery, and intraoperative and early postoperative complications. To assess postoperative stress on patient’s physiology, postoperative pain score will be assessed using visual analog scale (VAS) at 1, 6, and 12 h. The time to resume normal solid feeding (as a surrogate marker of disappearance of postoperative nausea and vomiting) will also be noted for all patients.

All the results will be analysed by appropriate statistical methods.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-15
• Last Update Posted: 2019-08-07

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Patients undergoing any of the transperitoneal laparoscopic renal surgery under general anesthesia.
• Only elective surgery Patients with ASA grade I and II status Minimum duration of surgery 2 hours Radiologically well-defined disease.

Exclusion Criteria

BMI >35 kg/m2 Patients with major co-morbidities having contraindication for general anesthesia Patients with history of previous transperitoneal laparoscopic or open surgery Patients in whom only a part of the surgery was performed laparoscopically Patients with major psychiatric illness Patients with pre-emptive additional analgesia for postoperative pain relief like nerve blocks or epidural analgesia Pregnant women.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative pain	6 hours

Secondary Outcome Measures

Name	Time	Method
Postoperative pain	1 hour
Heart Rate	before insufflation (T1), 10 min after insufflation (T2), 10 min before desufflation (T3), and 10 min after desufflation (T4).
mean arterial pressure (MAP)	before insufflation (T1), 10 min after insufflation (T2), 10 min before desufflation (T3), and 10 min after desufflation (T4).
pH	before insufflation (T1), 10 min after insufflation (T2), 10 min before desufflation (T3), and 10 min after desufflation (T4).
Time to resume normal feeding	Days
EtCO2	before insufflation (T1), 10 min after insufflation (T2), 10 min before desufflation (T3), and 10 min after desufflation (T4).

Trial Locations

Locations (1)

Sanjay Gandhi Postgraduate Institute of Medical Sciences; 🇮🇳 Lucknow, UTTAR PRADESH, India

Sanjay Gandhi Postgraduate Institute of Medical Sciences

🇮🇳Lucknow, UTTAR PRADESH, India

Dr Sanjoy Kumar Sureka

Principal investigator

8004904749

drsksureka@gmail.com