Anaesthesia for Laparoscopic Sleeve Gastrectomy

• Sponsor: Menoufia University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03029715
• Collaborator: (none)
• Enrollment: 100
• Arms: 2
• Duration (Months): 31

Study Details

Study Description

Brief Summary

Background: Laparoscopic sleeve gastrectomy is commonly done with total intravenous anaesthesia (TIVA) or balanced anaesthesia using intravenous and an inhalation agent. It is still unclear which anaesthesia regimen is better for this group of patients. The present study was carried out to compare the use of inhalation anaesthesia technique using desflurane and TIVA using propofol and dexmedetomidine.

Methods: This randomized controlled trial was carried out on 100 morbidly obese patients undergoing laparoscopic sleeve gastrectomy. The patients were randomized into two equal groups, inhalational group and TIVA group for anaesthesia maintenance. All patients received general anaesthesia and induced with propofol, remifentanil and cis-atracurium. In inhalation group, anaesthesia was maintained by desflurane in oxygen air mixture while in TIVA group anaesthesia was maintained by intravenous propofol and dexmedetomidine infusion. Intra-operative vital signs and anaesthesia recovery time were recorded. Post-operative nausea, vomiting, pain score, analgesic consumption, the onset of bowel movement, and post-anaesthetic care unit (PACU) stay were studied for both groups.

Condition or Disease	Intervention/Treatment	Phase
Obese	Drug: Propofol; Drug: Remifentanil; Drug: Dexmedetomidine; Drug: Desflurane	N/A

Detailed Description

After obtaining the ethics committee approval of El Menoufia University hospital and the informed written consent from the patients, a hundred morbidly obese patients scheduled for sleeve gastrectomy were recruited for the study. Patients with history of cardiac comorbidity, chronic obstructive lung disease, drug abuse, expected difficult intubation patients, and patients with history of allergy to the study drugs were excluded from the study. Patients from 30 to 50 years old of both sexes were randomly allocated using computerized software into two groups, fifty patients in each group. Patients in inhalation group received intra-operative inhalational anaesthetic while patients in TIVA group received TIVA for anaesthetic maintenance.

All patients received a routine premedication with oral sodium citrate 15ml [0.3 molar (1.16gm)] and intravenous (IV) 4mg ondansetron fifteen minutes before induction. Patients in both groups were connected to the routine monitoring and bispectral index (BIS) upon arrival to theatre. Anaesthesia induction for both groups was carried out by 0.5-1 mcg kg -1 remifentanil, 2-3mg kg-1 propofol, and 0.6 mg kg-1 rocuronium. Endotracheal intubation was done with the appropriate tube size.

In the inhalational group, anaesthesia was maintained by desflurane in low flow oxygen air mixture 60/40%. In the TIVA group, anaesthesia was maintained using propofol 8-12 mg kg-1 h-1 and dexmedetomidine 0.5-1ugkg-1h-1. Remifentanil infusion of 0.05-2 µg kg-¹min-¹ was administered for both groups. Muscle relaxation was maintained in both groups by rocuronium infusion at a rate of 10-12ug kg1min-1. Depth of anaesthesia was monitored by bispectral index and anaesthetics were adjusted in both groups to obtain BIS of 40 to 60 by giving boluses of 0.5ug kg-1 remifentanil. The total boluses of intra-operative remifentanil were recorded. At the end of the procedure all patients received 0.6mg atropine and sugammadex 16mg kg-1 to reverse the effect of rocuronium. Patients were extubated and transferred to the post-anaesthetic care unit (PACU).

Post-operative pain was monitored using visual analogue score (VAS) at PACU. Morphine sulphate 2 to 3 mg was given if the VAS was > 4. Intravenous paracetamol 1gm and/or ketorolac 30 mg were given eight hourly intravenously if needed (VAS ≥3). Post-operative ondansetron 4mg every eight hours was given if required.

Haemodynamics including heart rate and mean arterial blood pressure (MABP) were recorded as a baseline and every fifteen minutes intra-operatively. Recovery time from anaesthesia using Aldrete score was recorded (the time from cessation of all anesthetics until complete recovery). 10 The incidence of post-operative nausea and vomiting, post-operative analgesic requirements, and the duration of PACU stay were recorded. Post-operative pain assessment using VAS from 0 to 10, where 0 means no pain and 10 is the worst pain the patient experienced. VAS was recorded at full recovery, every 15 minutes in PACU until discharge PACU. Time of onset of post-operative bowel movement was recorded.

Statistical analysis:

Sample size calculation was calculated using Graphed Instant statistics version 3. Based on the previous, studies propofol was expected to produce a drop in the MABP after induction of anaesthesia by about 10 mmHg with a standard deviation of 15 mmHg so by choosing level of significance 0.05 and power of 90%; the calculated sample size was 48 patients so that the number of patients randomized in each group was fifty patients to ensure reliable results.

Statistical analysis was done using SPSS 19 (SPSS Inc, IBM company, Chicago,USA). The patients' sex, American society of anaesthetists (ASA) status and incidence of side effects were analyzed using the chi-square χ2-test. Other parameters were compared using student t-test. For comparisons within the same group, paired t-test was used where for comparisons between groups; unpaired t-test was used. P-value less than 0.05 was considered statistically significant.

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Comparative Study Between Inhalational Anaesthesia and Total Intravenous Anaesthesia (TIVA) With Dexmedetomidine for Morbidly Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy
• Study Start Date: Feb 1, 2014
• Actual Primary Completion Date: Mar 1, 2016
• Actual Study Completion Date: Sep 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Other: Intravenous anaesthesia Propofol Dexmedetomidine Remifentanil	Drug: Propofol; Total intravenous anaesthesia.; Other Names: TIVA group ; Drug: Remifentanil; Narcotics; Other Names: TIVA group and inhalation group ; Drug: Dexmedetomidine; Total intravenous anaesthesia; Other Names: TIVA group
Other: Inhalation anaesthesia Desflurane Remifentanil	Drug: Remifentanil; Narcotics; Other Names: TIVA group and inhalation group ; Drug: Desflurane; Inhalation anaesthesia.; Other Names: Inhalation group

Outcome Measures

Primary Outcome Measures

1. Analgesic Requirements. [Within one hour after surgery]

   Total paracetamol consumption.

Secondary Outcome Measures

1. The Intra-operative Mean Arterial Blood Pressure. [During operation and follow-up, an average of 2 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Morbid obese scheduled for sleeve gastrectomy.

Exclusion Criteria:

• Patients refusal and allergy to drugs used.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Menoufia University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr Ezzeldin Ibrahim, Assistant Professor in anaesthesia, intensive care, and pain medicine., Menoufia University
• ClinicalTrials.gov Identifier: NCT03029715
• Other Study ID Numbers: MenoufiaU2016/2
• First Posted: Jan 24, 2017
• Last Update Posted: Sep 16, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Dr Ezzeldin Ibrahim, Assistant Professor in anaesthesia, intensive care, and pain medicine., Menoufia University: Sleeve gastrectomy; TIVA
• Additional relevant MeSH terms: Dexmedetomidine; Remifentanil; Propofol; Desflurane

Study Results

Participant Flow

Arm/Group Title	Intravenous Anaesthesia	Inhalation Anaesthesia
Arm/Group Description	Propofol Dexmedetomidine Remifentanil Propofol: Total intravenous anaesthesia. Remifentanil: Narcotics Dexmedetomidine: Total intravenous anaesthesia	Desflurane Remifentanil Remifentanil: Narcotics Desflurane: Inhalation anaesthesia.
Period Title: Overall Study
STARTED	50	50
COMPLETED	50	50
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Intravenous Anaesthesia	Inhalation Anaesthesia	Total
Arm/Group Description	Propofol Dexmedetomidine Remifentanil Propofol: Total intravenous anaesthesia. Remifentanil: Narcotics Dexmedetomidine: Total intravenous anaesthesia	Desflurane Remifentanil Remifentanil: Narcotics Desflurane: Inhalation anaesthesia.	Total of all reporting groups
Overall Participants	50	50	100
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	35.31 (10.43)	34.35 (11.15)	34.83 (10.79)
Sex: Female, Male (Count of Participants)
Female	35 70%	33 66%	68 68%
Male	15 30%	17 34%	32 32%
Region of Enrollment (Count of Participants)
Egypt	50 100%	50 100%	100 100%

Outcome Measures

1. Primary Outcome

Title	Analgesic Requirements.
Description	Total paracetamol consumption.
Time Frame	Within one hour after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sleeve Gastrectomy 1	Sleeve Gastrectomy 2
Arm/Group Description	Propofol Dexmedetomidine Remifentanil Propofol: Total intravenous anaesthesia. Remifentanil: Narcotics Dexmedetomidine: Total intravenous anaesthesia	Desflurane Remifentanil Remifentanil: Narcotics Desflurane: Inhalation anaesthesia.
Measure Participants	50	50
Mean (Standard Deviation) [mg]	3.56 (1.01)	1.67 (1.03)

2. Secondary Outcome

Title	The Intra-operative Mean Arterial Blood Pressure.
Time Frame	During operation and follow-up, an average of 2 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sleeve Gastrectomy 1	Sleeve Gastrectomy 2
Arm/Group Description	Propofol Dexmedetomidine Remifentanil Propofol: Total intravenous anaesthesia. Remifentanil: Narcotics Dexmedetomidine: Total intravenous anaesthesia	Desflurane Remifentanil Remifentanil: Narcotics Desflurane: Inhalation anaesthesia.
Measure Participants	50	50
Mean (Standard Deviation) [mmHg]	71.05 (3.06)	62.7 (2.98)

Adverse Events

Time Frame	During operation and follow-up, an average of 2 hours
Adverse Event Reporting Description	Nausea and vomiting
Arm/Group Title	Intravenous Anaesthesia		Inhalation Anaesthesia
Arm/Group Description	Propofol Dexmedetomidine Remifentanil Propofol: Total intravenous anaesthesia. Remifentanil: Narcotics Dexmedetomidine: Total intravenous anaesthesia		Desflurane Remifentanil Remifentanil: Narcotics Desflurane: Inhalation anaesthesia.
All Cause Mortality
	Intravenous Anaesthesia		Inhalation Anaesthesia
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Intravenous Anaesthesia		Inhalation Anaesthesia
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/50 (0%)		0/50 (0%)
Other (Not Including Serious) Adverse Events
	Intravenous Anaesthesia		Inhalation Anaesthesia
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/50 (0%)		0/50 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.