Injected anaesthetic versus inhalational anaesthetic for laparoscopic nephrectomy

Phase 3

Completed

• Conditions: Other disorders of kidney and ureter in diseases classified elsewhere,

• Registration Number: CTRI/2020/03/023733
• Lead Sponsor: CHRISTIAN MEDICAL COLLEGE

Brief Summary

Conventionally, inhalational agents are used for maintenance of anaesthesia in laparoscopic surgeries. These patients always present with multiple co-morbidities. Maintenance of anaesthesia with inhalational agent (0.9 to 1 MAC) causes haemodynamic compromise especially in diabetic and hypertensives. As anaesthesia time progresses (> 3 hours) when we use inhalational agents, the recovery time from anaesthesia also prolonging thereby delaying extubation time and the discharge time from PACU.  The postoperative nausea and vomiting (PONV)is higher in laparoscopic surgeries which is not attenuated by inhalational agent. We are hypothesizing that the total intravenous anaesthesia (TIVA)  attenuate stress response better compared to inhalational agents, because of its anti-inflammatory and anti-oxidant properties. High concentration of propofol (within the therapeutic range) decreases the CVP without decreasing the cardiac output, ensures the haemodynamic stability. TIVA decreases the incidence of post-operative nausea and vomiting, decreases the tumour recurrence because of its anti-tumour effect on immune cells. All the above mentioned effects will help the patients to recover better following anaesthesia thereby improves the post-operative recovery profile. In this randomized, active comparator study we will compare the recovery profile of those receiving total intravenous anaesthesia with those receiving sevoflurane for maintenance of anaesthesia while undergoing laparoscopic nephrectomy.One-hundred and twenty, ASA 1 and 2 patients aged between 18 and 65 years, undergoing elective laparoscopic nephrectomy will be assigned to either TIVA with propofol (Group A) or inhalational with sevoflurane group (Group B) in a 1:1 randomization using variable block sizes of 4, 6 or 8. While the TIVA group (Group A) will receive only propofol for both induction and maintenance, the sevoflurane group (Group B) will undergo induction with propofol and maintenance with sevoflurane.  Participants will be anaesthetized by one of three anaesthesiologists who are the coinvestigators who will follow a standardized protocol. We will titrate the anaesthetic to target a Bispectral (BIS) index of 40-60. Total duration of anaesthesia, surgery, Total dose of opioid and propofol used during surgery will be documented. The recovery from anaesthesia will be assessed by recovery room nurses who will remain blinded to the study assignment.  The primary intention to treat analysis will include all randomised patients who have a valid primary endpoint assessment for quality of recovery which will be assessed at 24 hours after surgery (24-26 hours) using a Quality of Recovery-15 (QoR-15) questionnaire by the primary investigator who is blinded about the study intervention. The time to recovery from anaesthesia will be assessed from cessation of anaesthetic to opening eyes to call. Fitness to discharge will be assessed using the modified Aldrette score every ten minutes till the score >=9. No patient will be excluded from the study. Primary outcome QoR 15 is measured at 24 hours after surgery and if this measurement is not possible because the patient is ventilated postoperatively, we cannot make this assessment. The primary analysis for efficacy will be a modified intention to treat analysis that includes all patients in whom the primary endpoint can be assessed. The secondary endpoints will continue to be assessed for all participants. A secondary per-protocol analysis will exclude, in addition, those whose surgery was converted to laparotomy.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-03
• Study Completion: 2021-10-27
• Last Update Posted: 2021-11-29

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

All patients undergoing elective laparoscopic nephrectomy ASA 1 and 2.

Exclusion Criteria

ASA 3 or more Allergic to local anaesthetics Serum creatinine >1.4mg/dl Psychiatric disorders Chronic opioid usage Steroid treatment Patient refusal.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the recovery profile measured by quality of recovery score 15(QoR-15), in patients receiving TIVA using propofol or Inhalational anaesthesia using sevoflurane for laparoscopic nephrectomy at 24 hours after surgery	24 hours

Secondary Outcome Measures

Name	Time	Method
To compare the intra-operative hemodynamic profile.	Intraoperative every 15 minutes from induction to extubation
To compare time taken to awaken from anaesthesia	Time of cessation of anaesthetic to time of obeying commands
Intraoperative analgesic requirement	Cumulattive analgesic use calculated at end of anaesthesia
To compare intraoperative vasopressor/ inotrope support requirement between two groups
To compare time taken to attain fitness for discharge from PACU	Assessed every 10 minutes from extubation till Aldrette score greater than 8
To compare the incidence of postoperative nausea and vomiting (PONV)	Number of episodes during the first 24 hours post operation
To compare the recovery profile, measured by quality of recovery score 15 at 48-hours post operation	48 hours post operation
To compare the total dose of morphine consumption at 24hours and 48 hours	24 and 48 hours postoperative
To compare the time to DRink (Time from extubation to the time at which the patient asks for oral fluids), time to EAt solids orally (Time from extubation to the time at which the patient asks for solid food) and the time to Mobilize with support (Time from extubation to the time at which the patient walks with support) (DREAM TIME)	Time from extubation to completion of each task on demand.
To compare the patient satisfaction	Postoperative 24 hours after extubation

Trial Locations

Locations (1)

Christian medical College; 🇮🇳 Vellore, TAMIL NADU, India

Christian medical College

🇮🇳Vellore, TAMIL NADU, India

VijayalakshmiR

Principal investigator

8903514505

aarvee93@gmail.com